MDAdvisor Fall 2014 by MDAdvantage Insurance Company of New Jersey

THE MISUSE AND ABUSE OF PRESCRIPTION MEDICATIONS: PART 1 CURRENT TRENDS

Virginia Allread, MPH, and Sindy Paul, MD, MPH

A REMINDER THAT PUBLIC HEALTH IS GLOBAL: NEW JERSEY MONITORING FOR EMERGING COMMUNICABLE DISEASES

Commissioner Mary E. O’Dowd, MPH Gerald N. Grob, PhD

THE EVOLUTION OF FIBROMYALGIA IN MODERN AMERICA

VOLUME 7 • ISSUE 4 • FALL 2014

Duty. Honor. Courage.

NEW JERSEY PHYSICIANS IN THE MILITARY

MDADVISOR: A JOURNAL FOR THE NEW JERSEY MEDICAL COMMUNITY

Now you know… MDAdvantage WE PROVIDE VALUE BEYOND INSURANCE. At MDAdvantage®, our mission is to be a haven of safety, stability and strength for New Jersey healthcare. We advocate for physicians and actively support the practice of medicine in New Jersey. We have earned a reputation for integrity, responsiveness and decisive management, and stand prepared to assist healthcare providers in facing the challenges associated with today’s changing healthcare environment.

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e to eco atio ns ay, com r, we r l sue tera rans D he n e s t e i in V W e d s te hi rve nd un t mb e e a o e V s r v e y a Da No icat r of nd e to uniform tion ono to ded ey a ontinu c h s r e l n e to s in I E c J ican like eful nd ew r t a e a N d r l ll Am e are g rved cing wou cians in crifi r se ent of a i w a s e s , y v s ld e e n ph wou whil perc hysicia ave y e e h r t n W n p o rs . u who r of vide ces r co than i i e o t r s e b c s p h um et pra are th le all n nd serv edical lthc . Wi m y a r s e a a h . t a m p mi l i ities pdate ther heir n ding step u o t u u l our d d c U n omm s an n to ives an ve ay, i ose l cian in our c gislati i tod ing h l s c a y s ve Le com ph on n a s p a r t e h u r s s e o p ho he Vete ur late te e wh of t heir ledge t uca our o w d r e thos ch in t i e s o w f v u ude pre kno s to and ring incl sa der so m e to ac d in ca e a r e e u u r t s tate a lik ll ve ur s is is hich fe e a o also re invol h g t t on a c r a lly, ote er, w encou mpa v i d l e l who ditiona i I w hw and Ad sey. hat l Sc out hae ew Jer ssues t c t i M i ge to in N he key from s r n e t o b n ti elec elves o R e m e m s s. them s i d e n t e h! r r 4t its e b em Nov y, erel Sinc any omp C O E e &C ranc man ge Insu r i a Ch anta Adv rsey D M e ew J of N

MDADVISOR

Dear Editor:

MDADVISOR

This year, New Jersey became the 14th state to pass legislation requiring physicians to inform women if they have dense breast tissue and requiring insurers to cover supplemental testing, such as breast MRI, screening breast ultrasound, and/or tomosynthesis (3D mammography) if the patient’s mammogram demonstrates dense breast tissue and/or if the patient has additional breast cancer risk factors. The legislation was crafted in a form that is fairly reasonable compared to some other states, applying only to women with extremely dense breasts (approximately 10 to 15 percent of women). Had the New Jersey legislation been less specific, the associated risks might outweigh the benefits. The biggest issue moving forward will be educating patients and managing the expectations of those who may want additional testing but don’t meet the criteria. Additionally, patients need to understand that although the law has been in effect since May, carriers are not required to cover these new tests until the patient’s next open renewal. The use of tools such as software systems to classify breast density using standardized criteria will help to make the new process objective and uniform.

PUBLISHER

Sincerely,

William F. Muhr, Jr., MD William F. Muhr, Jr., MD South Jersey Radiology Associates

A Journal for the New Jersey Medical Community

LETTERS TO THE EDITOR

PATRICIA A. COSTANTE, FACHE Chairman & CEO MDAdvantage Insurance Company of New Jersey PUBLISHING & BUSINESS STAFF CATHERINE E. WILLIAMS Senior Vice President MDAdvantage Insurance Company of New Jersey JANET S. PURO Vice President MDAdvantage Insurance Company of New Jersey 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 OF NEW JERSEY 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 of New Jersey 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 of New Jersey. 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 | FALL 2014

FALL 2014 – CONTENTS

Cover photo, clockwise starting from top left: Colonel Lisa Hou, DO; Colonel Gary Brickner, MD; Captain Joseph Costabile, MD; Lieutenant Colonel Mark Leone, DO.

LETTER FROM MDADVANTAGE® CHAIRMAN & CEO PATRICIA A. COSTANTE

REFLECTIONS OF MILITARY PHYSICIANS | Interviewed by Catherine E. Williams and Maria Falca-Dodson

THE MISUSE AND ABUSE OF PRESCRIPTION MEDICATIONS: PART 1 CURRENT TRENDS | By Virginia Allread, MPH, and Sindy Paul, MD, MPH

NEW JERSEY FALL ELECTION UPDATE | By Michael C. Schweder

A REMINDER THAT PUBLIC HEALTH IS GLOBAL: NEW JERSEY MONITORING FOR EMERGING COMMUNICABLE DISEASES | By Commissioner Mary E. O’Dowd, MPH

THE EVOLUTION OF FIBROMYALGIA IN MODERN AMERICA | By Gerald N. Grob, PhD

BUILDING HEALTH IN NEW JERSEY AND BEYOND: AN INTERVIEW WITH RISA LAVIZZO-MOUREY, MD, MBA, AND BETSY RYAN, ESQ. | By Steve Adubato, PhD

BECOMING ADVOCATES AND CATALYSTS | By Leila Mady, MD, PhD, MPH - Emerging Medical Leaders Advisory Committee Member ONLINE ARTICLE – VISIT OUR WEBSITE FOR FULL ARTICLE AT: WWW.MDADVANTAGEONLINE.COM/MDADVISOR

E37

PRACTICAL LESSONS FROM HHS’S 2011-2012 REPORT ON HIPAA BREACHES OF UNSECURED PHI | By Leonardo M. Tamburello, Esq., CIPP/US

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f o s n o i t c Refle

hen ht: T g i r o t Left

Physicians have always been a key component of the military, serving in every conflict–World War II, Korea, Vietnam, Iraq, Afghanistan, and all others before and in between. They too are part of a volunteer force since the draft ended 40 years ago. Their service frequently places them in harm’s way but also on the cutting edge of new developments in medicine–especially in trauma care and surgery. Currently, less than one percent of Americans are serving our country in uniform, versus 16 percent during World War II. Mirroring this drop in numbers is the small number of physicians serving. With physicians in high demand and short supply, there is a great reliance on the National Guard and the Reserves. This usually results in multiple deployments for those willing to serve. MDAdvisor staff interviewed four New Jersey physicians who have served in various capacities in our military and who have deployed to support the Global War on Terror. They shared with us their experiences and the resulting impact on their personal lives, their civilian medical practices and their families. Some com-

MDADVISOR | FALL 2014

CAPT Costabile

Interviewed by Catherine E. Williams and Maria Falca-Dodson

& Hou LTCs

ner Brick

mon threads emerged in these discussions–including the overriding sense of camaraderie, the commitment to our country and the people they serve, and an impressive display of humility in their service. They are not unlike countless unnamed physicians who have served in other eras, including one in particular who served during the Cold War and who feels he owes a great deal to the U.S. Air Force in which he voluntarily served for two years. This physician attributes to the Air Force his knowledge of leadership, his sense of confidence, an understanding of mission and unity of effort and even his choice of specialty. The physicians who speak to us in this article are Colonel Gary Brickner, MD, U.S. Army-New Jersey Army National Guard; Colonel Lisa Hou, DO, U.S. Army-New Jersey Army National Guard; Lieutenant Colonel Mark Leone, DO, U.S. Air Force-New Jersey Air National Guard (ret); and Captain Joseph Costabile, MD, U.S. Navy Reserves-4th Medical Battalion/4th Marine Logistics Group.

INTRODUCTIONS

COL Brickner

COL Brickner: By coincidence, COL Brickner’s practice decided to drop obstetrics and do only gynecology just before September 11, 2001. That’s when he decided, at 52 years old, to contribute to the war effort. “I felt I had something to offer, and the National Guard agreed,” he remembers. “There were times when I was over there, and I’d ask myself, ‘What were you thinking?’ But I wouldn’t change my decision. I have no regrets.” Brickner was commissioned in the summer of 2002, and the first of his three deployments was to Afghanistan in October 2004 doing combat patrols. He trained medics–cer-

tainly not to our standards, he notes, but to the basic standards to which all soldiers are trained. Another time, his job was to show Afghani doctors how to set up an ambulance, which doesn’t sound like much–but it was tough going, considering that the Afghans were using their ambulances to cart around wood for fuel. Brickner’s second deployment was to Iraq during the surge (spring to fall 2007). At that time, the traumatic brain injury (TBI) issue was huge, and soon Brickner learned how to look in a soldier’s eyes and know quickly if the brain injury was grade I, II or III. “But,” he remembers, “these guys didn’t want to come out of the line; they could hardly remember their name, and they wanted to go back out.” For his third deployment in 2011, Brickner went back to Afghanistan with the detainee mission for about 105 days. For Brickner, serving in the military has been the greatest experience of his life. “In civilian life,” he says, “everyone’s out doing their thing. But when you’re in a combat zone, and you’re given a mission, everyone is pushing in the same direction. That’s the secret of being a good soldier. Very few screw-ups, very few people gaming the system over there. It’s nice to be part of that because you don’t get that very often in most of what you do in life. To me, there’s no higher honor than wearing the country’s uniform. I felt that way in 2001, and I feel that way today. I’ve never regretted a day. “ COL Hou: Those who enter the military are often inspired to do so by others who also serve. This was the case for COL Hou. Hou spent a lot of time with her grandfather, who was a two-star general with the Chinese Nationalist Army, listening to his war stories, and soon was hooked on the idea of serving her own country. Her other inspiration was Dr. Brian Trainor, a fellow medical school student. When Hou was in her second year, Trainor was doing a

Lt Col L eone

Then MAJ Hou

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dency, and then, feeling a desire to give back to the Air Force, he joined the New Jersey Air National Guard in 1990. He had numerous breaks in service because of the impact on his medical practice, but kept coming back due to his commitment to serve. Right after the attacks on September 11, 2001, Leone deployed to Oman to support Operation Enduring Freedom in Afghanistan. “I believed in what I was doing,” says Leone. “It gave me a chance to serve, so I can say that I did something for my country. I usually tell other doctors to join the military because it’s a diversion from the normal job and duties, and you get to experience things you wouldn’t otherwise experience.”

CAPT Costabile

Lt Col Leone

CAPT Co stabile

research project that involved Army pilots from the New Jersey Guard, and he got her involved. “I got to fly in the helicopters,” Hou says. “I just thought it was the coolest thing. Not long after that, I talked to a recruiter, and here I am almost 20 years later.” Hou began her military career with the Medical Detachment Unit and is now in charge of that unit today. Although military physicians often deploy as individual mobilees and get attached to units with people they don’t know, Hou was happy to find that on her first deployment to Iraq in 2005 she was assigned to the New Jersey unit with two other doctors and a dentist from New Jersey. “ In addition to taking care of soldiers, on my days off, I participated in many off-post humanitarian missions,” she recalls, “and I loved it. We were offering something to the local people, and it was really fulfilling.” Hou stayed all four rotations, almost a year. Her second deployment was in 2011 for 90 days in Afghanistan with the 45th BCT from the Oklahoma National Guard. “It was a very different experience because when I was in Iraq we were in the Level 2 medical facility, but in Afghanistan, I was in a Level 1 aid station and was the only doctor there, overseeing the healthcare needs of up to 900 soldiers and contractors. I had as good an experience, just very different.” Overall, Hou enjoyed being part of an organization in which she was needed and was recognized for her skills. “In the military, as a whole,” she says, “you create very special bonds with your fellow soldiers when you deploy. Even all these years later, I’m still close with the medics from my deployment.” Lt Col Leone: After a total of almost 21 commissioned years of service, Lt Col Leone says he had a wonderful experience across the board and would definitely recommend military service to others. Leone served four years active duty, from 1979 to 1983, as an Air Force Reserve in the Health Professional Scholarship Program. He then served four years active duty with an attack unit in Florida to pay back his medical school. After finishing his military obligation, Leone finished his resi-

MDADVISOR | FALL 2014

CAPT Costabile: CAPT Costabile joined the military because he is a firm believer that you have to give something back to your community. “We live in a great country,” he says, “and we have the freedoms and the luxuries that most nations, without at least a strong military for defense, don’t have. I thought I’d give some payback to my country. My original game plan was just to spend a couple of years providing medical services and then get out…that was 20 years ago.” During most of his time, Costabile has served in the Navy, supporting the Marine Corps. He went to Kuwait in 2005 from January until Thanksgiving and was

the Reserves, particularly general surgeons. Yet our soldiers continue to need medical care. “Why,” he asks, “would I continue to spend one weekend a month and more than two weeks a year in the Reserves? Because it is my privilege to serve the men and women who have such an incredible amount of devotion to their units, to the Corps, to the country. Because these people need the type of care that doctors can provide. It is my privilege to spend time with them. It is my privilege to put on the uniform. I take my responsibilities as a Naval Medical Officer very seriously.” THE IMPACT OF MILITARY SERVICE ON A MEDICAL PRACTICE In the beginning, COL Brickner found that the weekend training drills were not much of an imposition on his practice. Then, when he had to go away for officer training for a few weeks in Texas, he almost felt it was like taking vacation time. But after he was commissioned, he was deployed three times, and that affected his

Right: Then MAJ Brickner

assigned to the Expeditionary Medical Facility-DALLAS, supporting the critically injured. Then in 2008, he went to Iraq for eight months. Costabile believes that the job of physicians in the military is even more important today with the military being pared down. He sees that the government depends on reservists, but knows we’re short-handed in

practice. “I always say when I’m deployed, or when a Guardsman is Cente deployed, 10 or r: COL Hou 12 other people deploy also. My associate worked almost a year without me in a very busy practice, so he was working pretty hard. My practice definitely took a financial hit.” The hit was not short-term by any means. By the time Brickner completed his third deployment, he’d been away almost 10 percent of the time since he started the practice in 2001. “You can’t make up that time,” he said, “and you can’t get that money back. I don’t think it stunted the growth of the practice, but it took a year of earnings out of my pocket.” COL Hou had a different experience and found that the greatest effect of military service on her practice was on patient retention. She believes that losing patients is the biggest issue for a physician with a private practice who has to serve. “If you’re not there,” she notes, “your patients are going to go somewhere else. On one hand, you want to do your duty, and you want to serve, but on the other hand, you’ve got your practice to consider. So, it’s a hard balance. That’s not to suggest that Hou did not suffer financially as well for her decision to serve our country. Her first practice closed after she deployed because she was away for so

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military position (New Jersey State Army Surgeon and Commander, New Jersey Army Medical Command), she feels it is just too much to do both effectively. Although it is impossible to entirely avoid the negative impact of deployment on a medical practice and on personal finances, Lt Col Leone and CAPT Costabile both found that the support of their partners and office e il b ta s o staff diminished that CAPT C impact. Leone got out of the Guard in 1992, when he had just bought a practice. At that time, he thought about giving up his commission, fearing he would lose his practice if he were tapped to be deployed. But he did not and went back to the Guard in 2000. With careful advance planning and supportive staff, Leone managed to balance his responsibilities and finances. “The practice actually worked out okay because I worked out a deal with my partner,” he recalls. “We hired a couple of residents, and I went on an hourly rate; he paid me for the hours I worked as opposed to salary in the business. We worked it out that he wouldn’t get crushed, and the practice survived. If the practice lost money, it was on my end, and I was being subsidized by the Air Force so it didn’t affect me as much. It was a collaborative

MDADVISOR | FALL 2014

Then MAJ Brickner

long. (She also went through a divorce at the same time, so it was an exceptionally difficult two years.) “I always had in my head that I wanted my own practice. So after my first practice closed, I spent a lot of time and money starting from scratch again, which was tough because I knew there was a good possibility I would deploy again.” Currently, Hou is practicing only part-time because with her current

effort that kept the practice going strong in my absence.” CAPT Costabile also credits the support of his partners with the survival of his practice. The first time he was deployed, he arranged to have his patients see his partners. Then when he was recalled again two years later, the partners, once again, stood by him. “The senior physician in our group,” says Costabile, “stated that although we can’t all join the military, by supporting me, the group could support the military and our country.” Costabile remembers that because of this attitude, there was never any pushback or issues, although he knew other physicians serving who had more difficult situations in their practices. THE EXPERIENCE OF RETURNING HOME Returning from a combat zone is never easy. COL Brickner believes that all returning military come back with post-traumatic stress. CAPT Costabile remembers standing in his foyer talking to a neighbor when someone lit a firecracker, and his first reaction was to duck, a completely normal response. Fortunately, most adapt quickly, with very few physicians suffering full-blown post-traumatic stress disorder (PTSD). Still, there are adjustments to be made. Some Vets find it tough to relate to their friends in the U.S. who have no idea what’s going on in the conflicts; others find it difficult to think about those they left behind. Brickner recalls the difficulty of talking to friends who would ask him about Afghanistan or Iraq. “I would get two sentences out, and they would change the subject,” he says. “The first few times it happened, I just couldn’t believe it. I don’t think they even heard what I said to begin with. I’m not sure people even realized what they were doing. Maybe there was some unconscious guilt that he’s serving and I’m not. I don’t know. This interview is probably the most I’ve talked about my deployments.” Costabile finds that returning home makes him feel

COL Hou

guilty because he feels bad for the people who replaced him. “I know what they are going through,” he says. “I feel guilty that somebody else is now experiencing all the hardships I had been through while I’m now enjoying the comforts of home.” For some returning military, life in the U.S. is a reality check. Costabile found that his perception of “discomfort” had changed. He recalls one day when he was driving his pickup truck in 90 degree weather with a jacket on, windows open with no air conditioning on. His neighbor couldn’t believe it. Costabile told him, “It’s not that hot. I’ve been hotter.” Costabile, along with Brickner and Hou, realized that there are things that Americans feel they absolutely can’t live without that, in fact, they really can. Hou learned to love the simple life where you don’t have all your worldly goods with you. “It actually was refreshing,” she says. “I came back and realized that I don’t always need all the bells and whistles of my life.” This realization has made it difficult for Brickner to listen to people complain about things. “There are people over there living in horrible conditions, and soldiers risking their lives to protect us,” he says. “It was tough to reconcile. It was like my tolerance for complaining Americans here was a little bit low at the time of my return home.” SKILLS AND EXPERIENCES BROUGHT HOME Most military doctors agree that the benefit of serving is a give-and-take arrangement. The doctors bring skills to the field, and they bring new skills, attitudes and perspectives home with them. In the skill arena, COL Brickner feels that his military time has taught him to get a lot done in a little time. “There would be two of us in the clinic,” he says, “and we would see 150 soldiers in a six-hour period. You had to

triage and make diagnoses really quickly. I now realize how much I can do when I have to.” In a similar way, Lt Col Leone says he has gained organizational skills. “The military,” he says, “gives you an opportunity to learn and to use that skill set.” CAPT Costabile found through his military experience that there is more than one way to apply learned skills. For example, he notes that his method of dealing with a patient who has lost a lot of blood has changed since his last deployment. “The first instinct,” he acknowledges, “is to give the patient packed cells. Well, that’s all well and good, but when you’re having an acute bleed, you’re not just bleeding out packed cells. You’re bleeding out the coagulation factors, platelets, all those things that make your blood clot. We were pretty quick on the trigger over in the Middle East to start using other components besides just packed cells. We start giving fresh, frozen plasma and platelets, too. That was a new approach for me.” COL Hou, too, has learned adaptive skills through her military work. “I’ve learned,” she says, “to work with what I have, especially when I have limited equipment. For example, I was putting tubes in someone’s ears, and I didn’t have a myringotomy knife; one of the dentists took one of his tools and filed it down, and we made our own.” Skill comes through in the toughest of times. In addition to specific skills, Hou believes that she has learned how to better interact with people. “Before my deployment,” she says, “I had just started a practice, and I was focused on that. Now, my work is more about serving people. To me, it’s not about building a practice and making money; it’s more about taking care of people.” CARING FOR VETERANS All of the doctors agree that their own military experience helps them better understand and care for our Veterans. Because CAPT Costabile understands exactly what our Veterans have sacrificed for this country, he feels strongly that every physician should take TRICARE insurance, regardless of the reimbursement rates. “It is unreasonable,” he believes, “to require a Veteran out in the middle of nowhere to drive 100 miles to see a doctor because nobody in the local community takes TRICARE. These are individuals who have written a blank check to the United States up to

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and including sacrificing their lives, and we can’t take care of them? I have a real issue with that.” COL Brickner believes that all physicians should take more time to talk with their Veteran patients, but he also knows that Veterans feel more comfortable talking to someone they know has been there. “It’s hard to describe an elephant to someone who’s never seen one,” he says. “Physicians have to do the proper assessment, of course, but even more than that, they have to listen to the soldier. The problem is that it is difficult to have these indepth conversations and still maintain an efficient practice in the current healthcare environment.” COL Hou feels the same way about her relationship with Veterans. “I really enjoy talking to patients who have served,” she says, “and I think they feel a little more connected and a little more comfortable talking to me as a physician and

telling me their problems just because I understand. Guardsmen and reservists come home and end up seeing civilian doctors who aren’t always looking for the wounds of war, especially those you don’t see.” Gary Brickner, MD, is an OB/GYN at the Brickner-Mantell Center for Women’s Health in Hamilton, NJ. Joseph Costabile, MD, is a surgeon with Virtua Surgical Group in South Jersey. Lisa Hou, DO, is an ENT-otolaryngologist in Swedesboro, NJ. Mark Leone, DO, practices family medicine at Voorhees Family Practice Associates in Voorhees, NJ. Catherine E. Williams is Senior Vice President, Business Development and Corporate Secretary, and Maria Falca-Dodson is Vice President, Strategic Initiatives, at MDAdvantage Insurance Company of New Jersey and is retired, U.S. Air Force.

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

Manhattan Office 630 Third Avenue, 5th Floor New York, NY 10017 Tel: 212-374-9555

www.vlhd-law.com 10

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New Jersey Office 10 Auer Court East Brunswick, NJ 08816 Tel: 732-613-5083

The MISUSE and ABUSE of

MEDICATIONS: Part 1 Current Trends

By Virginia Allread, MPH, and Sindy Paul, MD, MPH The epidemic of prescription drug abuse has triggered a resurgence in heroin abuse by young people. Heroin is a less-expensive analogue of prescription painkillers that delivers a stronger high and is currently more readily available than ever in areas with suburban and rural ZIP codes.1 The abuse and misuse of prescription medications and consequent heroin addiction have directly impacted rates of admission to drug treatment facilities; additionally, injection may put users at risk of transmitting or acquiring blood-borne pathogens, particularly hepatitis C and HIV. This article reviews national and New Jersey-specific data on the misuse of prescription medications, the relationship between prescription painkillers and heroin use, some of the reasons why prescription painkiller sales have increased dramatically in the United States, the importance of screening for addiction and resources for referrals. THE NATIONAL PICTURE In November 2011, the Centers for Disease Control and Prevention (CDC) reported that deaths from prescription painkillers–most notably unintentional overdose–had reached epidemic levels2 and identified prescription pill abuse

MDADVISOR | FALL 2014

as the fastest-growing drug problem in the United States (see Figure 1). Since 2003, unintentional drug overdoses from opioid analgesics have caused more overdose-related deaths than cocaine and heroin combined. The following data were reported by the CDC for 2010:2 ■ Nearly 15,000 people died of an overdose involving prescription painkillers. ■ 1 in 20 people in the United States (age 12 or older) reported using prescription painkillers for nonmedical reasons (defined as use without a prescription or medical need). ■ Enough prescription painkillers were prescribed to medicate every American adult around the clock for a month. The CDC reported that for every unintentional opioid analgesic death, there are the following additional drug-related events:2 ■ 461 reported nonmedical uses of opioid analgesics ■ 161 reports of drug abuse or dependence ■ 35 emergency department visits ■ 9 people admitted for substance abuse treatment

Figure 1. Rates of Opioid Pain Reliever (OPR) Overdose Death, OPR Treatment Admissions and Kilograms of OPR Sold, United States, 1999–2010

Note. Age-adjusted rates per 100,000 population for OPR deaths, crude rates per 10,000 population for OPR abuse treatment admissions and crude rates per 10,000 population for kilograms of OPR sold. Reprinted from “Vital Signs: Overdoses of Prescription Opioid Pain Relievers–United States, 1999–2008,” by the Centers for Disease Control and Prevention, November 4, 2011, Morbidity and Mortality Weekly Report, 60(43),1487–1492. Copyright 2011 by the Centers for Disease Control and Prevention.

MISUSE OF PRESCRIPTION PILLS AND HEROIN ADDICTION Many sources, both published and anecdotal,4,5 have stated that the use and misuse of prescription pills is becoming more prevalent among suburban and rural young people in the United States and is leading to heroin

Table 1.

2009 Overdose Deaths in New Jersey

NUMBER OF DEATHS

CAUSE

PRESCRIPTION PAINKILLER USE IN NEW JERSEY Statistics for New Jersey mirror national trends. From 2006 to 2011, the number of drug treatment admissions in New Jersey for opioid pill addiction tripled. Nearly half of these patients were age 25 or younger. In 2010, New Jersey had 7,238 admissions to state-licensed or certified substance abuse treatment programs as a result of prescription painkiller abuse. This is an increase of nearly 2,000 from the previous year’s admissions and an increase of more than 5,000 from 2005. Prescription drug abuse-related mortality increased by 51 percent in New Jersey from 6.5/100,000 population in 1999 to 9.8/100,000 population in 2010.3 In addition to the devastating effects on users and their families, misuse and abuse of prescription painkillers is expensive, costing the United States an estimated $53.4 billion per year in lost productivity, medical costs and criminal justice costs.3

Prescription opioid overdose

180

Heroin overdose

110

Cocaine overdose

Combination of prescription opioids, heroin and cocaine

Prescription opioids and heroin

109

Prescription opioids and cocaine

Combination of heroin and cocaine

Other drugs

103

Total drug overdoses

752

Reprinted with permission from “Overdose Prevention Campaign New Jersey Overdose Statistics,” by Drug Policy Alliance, November 26, 2012.

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Table 2.

2009 Overdose Deaths by County in NJ

COUNTY

NUMBER OF DEATHS Atlantic

Bergen

Burlington

Camden

Cape May

Cumberland

Essex

Gloucester

Hudson

Hunterdon

Mercer

Middlesex

Monmouth

Morris

Ocean

Passaic

Salem

Somerset

Sussex

Union

Warren

Total

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ILLICIT DRUG USE IN NEW JERSEY Prescription and illicit drug overdose (as shown in Table 1) has become the leading cause of accidental death in New Jersey, surpassing automobile accidents: In 2009 in New Jersey, 752 people died from drug overdoses7; in comparison, 583 died from motor vehicle-related causes.8 Deaths, of course, are just the tip of the iceberg: While non-fatal overdoses have been described anecdotally, specific statistics on these events are not currently available. According to the Drug Policy Alliance, almost 6,000 people have died from drug overdoses in New Jersey since 2004; in 2009, opioids were involved in more than 75 percent of drug overdose deaths. As shown in Table 2, the five counties with the highest numbers of drug overdose deaths are Camden, Essex, Middlesex, Monmouth and Ocean.7

752

Reprinted with permission from “Overdose Prevention Campaign New Jersey Overdose Statistics,” by Drug Policy Alliance, November 26, 2012.

addiction. The transition from pills to heroin “happens when the medicine cabinet runs dry and they can no longer afford, on the black market, to use the pill form and transition on to cheap bags of heroin,” said John Hulick, head of Governor Chris Christie’s Council on Alcohol and Drug Abuse (GCADA). Dan Goldberg and James Queally summarized the supply and subsequent transition from pills to heroin quite eloquently in their article for The Star-Ledger, saying: “The [heroin] market was flooded, the price has dropped, and with a generation of young, tech-savvy opiate addicts running low on cash and [prescription] pills, the demand [for heroin] has exploded. … There were so many painkillers out there in people’s medicine cabinets that it just created a massive wave of heroin users. When the pills became too scarce or too expensive, addicts still needed to get high and so 6 they switched to heroin.” Rick Incremona, First Assistant Prosecutor in Monmouth County, likened the graduation from prescription pain pills to heroin to switching from a name brand to the generic. “They like the high they have gotten from prescription narcotics but are looking for a cheaper, more readily available alternative,” and they found it in heroin.6

RISK OF BLOOD-BORNE PATHOGEN INFECTION A 2001 report by the CDC stated that by 1993 the proportion of persons admitted to New Jersey addiction treatment centers for illicit drug use who reported injecting drugs had increased, reversing a decline that began in

Figure 2. Acute Hepatitis C Case Reports, New Jersey 2006–2012

Reprinted with permission from “Injecting Drug Use Trends in New Jersey,” by S. Quinless, V. Allread, & G. Treisman, 2013, New Jersey AIDSLine.

approximately 1980.9 This report suggested substantial increases in injection use among young adult heroin users throughout the state and an increase in heroin use among young adults who resided in suburban and rural New Jersey. This trend has continued into the 2000s and, over the past decade, has become more evident. One of the many issues associated with injecting drug use is the risk of blood-borne pathogen transmission. Dr. Ronald Valdiserri, Deputy Assistant Secretary for Health, Infectious Diseases, and Director, Office of HIV/AIDS and Infectious Disease Policy, U.S. Department of Health and Human Services, wrote of an emerging epidemic of hepatitis C infection among young injecting drug users in rural and suburban settings.10 Evidence of an emerging epidemic came from surveillance data shared by Massachusetts in 2010 that showed an increase in hepatitis C among persons aged 15–24 between 2002 and 2009. The young people being reported were from all over the state, almost all outside metropolitan Boston, primarily White and equally male and female. In-depth interviews with a number of these hepatitis Cpositive young people uncovered that most were injecting drug users who had started opioid use by first misusing oral oxycodone approximately 1–1½ years before transitioning to injecting heroin.11 The editorial note that followed the Massachusetts study stated: “Although similar increases in human immunodeficiency virus (HIV) infection were not identified for this age group, increases in reports of hepatitis C infection among injecting drug users might be a harbinger

of increases in injecting drug use-associated HIV.”9 Unlike Massachusetts, New Jersey has not yet witnessed the acute hepatitis C epidemic seen in some other states.12, 13 Even though reports of acute hepatitis C cases have been increasing since 2009, the number of infections in 2012 was lower than in 2006, as illustrated in Figure 2. Although acute hepatitis C reports are still relatively low (71 in 2012), 70 percent of New Jersey’s cases in 2012 were attributed to injecting drug use (see Figure 3).13 HIV AND INJECTING DRUG USE IN NEW JERSEY New Jersey currently ranks fourth in the nation for overall cumulative HIV cases and has the largest proportion of women infected with AIDS in the United States.14 Of the 76,454 adults and adolescents in New Jersey reported since 1981 to have HIV or AIDS (cumulative HIV/AIDS case reports), 27,614 (36 percent) acquired HIV through injecting drug use, another 2,339 (3 percent) were men who had sex with men who were injecting drug users and another 3,763 (5 percent) acquired HIV through sex with an injecting drug user. In total, 33,716 (44 percent) of New Jersey’s HIV infections are attributable, directly or indirectly, to injecting drug use.15 Only Connecticut and Puerto Rico attribute a higher percentage of their HIV cases to injecting drug use.16 Considered in isolation, the cumulative numbers of HIV transmitted through injecting drug use provide a misleading image of today’s epidemic. In recent years, the number and percentage of HIV cases transmitted

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this way have dropped dramatically in the United States and in New Jersey (see Figures 4 and 5). In 2012, 56 New Jersey residents were reported to have acquired HIV or AIDS through injecting drug use, 3 percent of that year’s total. This trend seems stable: As of the first six months of 2013, 4 percent of reported HIV or AIDS reports were 17 due to injecting drug use. The drop in the number of injecting drug users diagnosed with HIV and hepatitis C is not due to a fall in the number of people injecting drugs, as that number has actually increased. Instead, decreasing HIV prevalence rates in injecting drug users may be due to program efforts to increase users’ access to clean syringes, through syringe access programs (SAPs) and pharmacies, efforts to promote safer injection practices, effects of antiretroviral therapies on infectivity of injecting drug users and possible changes in risk networks and other social mixing patterns that vary from place to place.18 In 2006, the State of New Jersey passed public law 2006, c. 99, the Blood-borne Disease Harm Reduction Act, which created up to six demonstration SAPs across the state. Between November 2007 and July 2009, five SAPs were established in areas with a high prevalence of HIV attributable to injecting drug use. The SAPs provide patients with clean needles and syringes in exchange for

used needles and provide access to a range of healthcare services. The SAPs in New Jersey are listed later in this article. SALES OF PRESCRIPTION PAINKILLERS ON THE RISE Since 1999, sales of prescription painkillers in the 19 United States have quadrupled. There are many reasons for this increase, both legitimate and illegitimate. The “modern” field of pain medicine is very new, having developed only in the past two to three decades. Before this time, treatments for pain were limited, and standardized tools for pain assessment were nonexistent. It is now well-recognized that historically pain was significantly under-treated and under-recognized. On this foundation, the medical community sought to improve the care of patients by ensuring their pain was recognized and treated.20 One of the better known national strategies was the “Pain as the 5th Vital Sign”–the Veterans Health Administration (VHA) strategy for pain management launched in 1999. In the article “Injecting Drug Use Trends in New Jersey,” Quinless, Allread and Treisman noted the potential link between the trend to prescribe more painkillers and the VHA’s campaign. The campaign urged physicians, nurses, nurses’ aides,

Figure 3. 2012 Acute Hepatitis C Exposure Risk Factors, New Jersey

Reprinted with permission from “Injecting Drug Use Trends in New Jersey,” by S. Quinless, V. Allread, & G. Treisman, 2013, New Jersey AIDSLine.

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Figure 4. Percentage of AIDS or HIV/AIDS Cases in New Jersey Due to Injecting Drug Use

Reprinted with permission from “Injecting Drug Use Trends in New Jersey,” by S. Quinless, V. Allread, & G. Treisman, 2013, New Jersey AIDSLine.

medical technicians, pharmacists, therapists, chaplains, social workers and other healthcare providers to screen, assess and document pain during initial assessment, and, when clinically required, to ensure, as an important first step, that unrelieved pain is identified and treated promptly. However, some question whether pain management had been improved by redefining it as the 5th vital sign. Although the routine measurement of pain by the 5th vital sign did not increase the quality of pain management, it may have increased patient expectation of pain management in the healthcare setting.21 A second, related, issue that has added to the prescription drug abuse debate is the increasing emphasis on patient satisfaction, a poorly described measurement that has, nonetheless, become a common metric when discussing healthcare quality. Doctors complain that trying to improve patient satisfaction often results in pressure to do things that may not be in the best interest of healthcare. This point was underscored by a study that showed improved patient satisfaction correlated with increased mortality.22 The current consumer model of healthcare has certainly contributed to the increased use of pain medications that are addictive and contribute to the abuse of prescription drugs. Some reports blame the black market supply of prescription painkillers on unscrupulous, yet qualified, physicians who practice “improper prescribing of pain medication.”23 Florida, in particular, has become the haven of black marketeers because of its inadequate

tracking and monitoring of prescription pain-relieving 23 medications. But it happens in New Jersey as well. According to a report by the State of New Jersey Commission on Investigation, “Some medical management companies … have transformed street-corner drug-dealing into an orderly and seemingly ordinary business endeavor, except for the hidden financial backing from individuals linked to organized crime, the multiple bank accounts for money-laundering, the expert help of corrupt physicians and the shady characters who recruit and deliver customers and provide security.”1 SCREENING AND REFERRALS FOR CARE Treatment for prescription drug addiction is limited. One author noted: “Of those in need of addiction treatment, only 11 percent receive it … less than 6 percent of referrals to treatment come from healthcare providers.” Many believe that these numbers show a failure to identify risky behavior.24 Given recent trends in prescription painkiller use, the public looks to prescribing clinicians to be judicious in their prescribing practice and to screen for addiction. Effective treatment of chronic pain should lead to increased function and capacity and should help patients overcome deficits produced by their pain. The increasing use of opiates, despite increasing dysfunction, fits the definition of addiction, which should trigger assistance to engage in rehabilitation and detoxification. Because of the risk of addiction, clinicians should monitor the patient’s level of function over time, including, if possible, the use of outside informants.

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Figure 5. Number of AIDS or HIV/AIDS Cases in New Jersey Due to Injecting Drug Use

Reprinted with permission from “Injecting Drug Use Trends in New Jersey,” by S. Quinless, V. Allread, & G. Treisman, 2013, New Jersey AIDSLine.

The warning signs of impending addiction include: ■ Changes in characteristic behaviors, such as changes in hygiene or in ability to keep appointments, taking pills more frequently than prescribed or lying to get a prescription renewed sooner than scheduled ■ Problems with occupations or relationships ■ Evidence of undisclosed medication use, such as emergency department visits If a provider suspects that a new patient has an opiate addiction, further data collection via interview and use of reliable and valid screening instruments is warranted. The Substance Abuse and Mental Health Services Administration (SAMHSA) has a number of screening tools available to help clinicians assess for opiate addiction. The Addiction Severity Index (ASI) and the ASI Lite (a shortened version of the ASI) are recommended.25 Referral for care is a problem for medical providers. Patients often do not follow referral suggestions, and those who do often encounter frustration in their efforts to get treatment. The available programs change, and the insurance issues of obtaining care are also constantly changing.26 Despite this, lists of programs are maintained by many substance use professionals, and a call to the emergency department social worker or similar professional may yield a list of up-to-date resources. There is clear evidence that the inclusion of on-site, integrated addiction care in clinics provides better engagement and better outcomes. Additionally, the presence of HIV-care provision on-site in substance abuse clinics has been effective in improving outcomes. Models of opiate maintenance programs that

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are integrated into HIV care have provided some of the best data for outcomes and clearly improve retention, HIV treatment success and addiction treatment success.27 A variety of resources are available in New Jersey for those who are using illegal drugs or misusing prescription medications. These resources include the following: ■ NJ Addictions Hotline. This hotline is staffed by trained, clinically supervised telephone specialists who are available 24 hours a day, 7 days a week, to educate, assist, interview and/or refer individuals and families battling addictions. Calls to 211 or 1-800-238-2333 are free, and information shared is confidential. More information is available at www.nj.gov/humanservices/das/treatment/hotlines. ■ Substance Abuse Treatment Directory. The State of New Jersey’s Department of Human Services, Division of Addiction Services, maintains a substance abuse treatment directory at: https://njsams.rutgers.edu/dastxdirectory/txdirmain.htm; the directory includes methadone maintenance programs–a harm reduction option appropriate for some clients. ■ Syringe Access Program. This program allows clients to obtain clean injection equipment and referrals to care. The Access to Reproductive Care and HIV (ARCH) Nursing Program is co-located with all of the SAPs, supporting the provision of services required by the 2006 legislation. The ARCH nurses provide harm reduction counseling, referral for care–including prenatal care if the client is pregnant; HIV, TB, hepatitis and STI testing as well as

immunizations. ARCH nurses have proven to be important assets to the healthcare network of 28 New Jersey. SAPs are located through the following programs: ■ South Jersey AIDS Alliance, Atlantic City, NJ, 609-572-1929, www.southjerseyaidsalliance.org ■ Camden AHEC, Camden, NJ, www.camden-ahec.org ■ Jersey City Syringe Access, Hyacinth AIDS Foundation, Jersey City, NJ, 201-432-1134, www.hyacinth.org ■ NJCRI, Newark, NJ, 973-483-3444, www.njcri.org ■ Point of Hope Syringe Access Program, Well of Hope Community Development Corporation, 207 Broadway, Paterson, NJ, 973-523-0700, www.wohcdc.org CONCLUSION The misuse and abuse of prescription drugs is a major public health issue in New Jersey and nationwide. The adverse outcomes of prescription drug addiction include acquisition of blood-borne pathogens, transition to illicit drug use and consequences of overdose, including death. Such a complex issue requires a combined approach by healthcare providers, medical regulation administrators and public health and law enforcement officials to address this burgeoning epidemic. New Jersey has taken a proactive approach in addressing the misuse and abuse of prescription medications. These actions will be described in detail in the second article in this series. Virginia Allread, MPH, is currently a public health consultant with experience in HIV prevention, care, treatment and support in the local, national and global arenas. Sindy Paul, MD, MPH, FACPM, is Medical Director for the New Jersey Board of Medical Examiners. 1

State of New Jersey Commission on Investigation. (2013, July). Scenes from an epidemic: A report on the SCIs

investigation of prescription pill and heroin abuse. www.nj.gov/sci/pdf/PillsReport.pdf. 2

Centers for Disease Control and Prevention. (2011, November).

Prescription painkiller overdoses in the U.S. November 2011. www.cdc.gov/VitalSigns/PainkillerOverdoses. 3

Trust for America’s Health. (2013, October). Prescription drug abuse: Strategies to stop the epidemic. http://healthyamericans.org/reports/drugabuse2013.

See, e.g., Illinois Consortium on Drug Policy, Roosevelt

University. (n.d.). Understanding suburban heroin use. www.robertcrown.org/files/Understanding_suburban_heroin_use. pdf. Note: This resource also explores some of the risk factors for drug addiction in young people, a topic beyond the scope of this paper. 5

State of New Jersey Governor’s Council on Alcoholism and Drug Abuse. (2014, March). 2014 report, confronting New Jersey’s new drug problem: A strategic action plan to address a burgeoning heroin/opiate epidemic among adolescents and young adults. http://greenagel.com/wpcontent/uploads/2014/03/HTF_Report_3-17-14.pdf.

Goldberg, D., & Queally, J. (2012, October 7). Heroin use among young in N.J. is up, and in more suburban areas. www.nj.com/news/index.ssf/2012/10/heroin_use_among_young _in_nj_i.html.

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

U.S. Department of Transportation, National Highway Traffic Safety Administration. (2010, August). Highlights of 2009 motor vehicle crashes. Traffic Safety Facts, Research Note. www-nrd.nhtsa.dot.gov/Pubs/811363.pdf.

“The adverse outcomes of prescription drug addiction include acquisition of blood-borne pathogens, transition to illicit drug use and consequences of overdose, including death.”

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Centers for Disease Control and Prevention. (2001, May 18). Trends in injection drug use among persons entering addiction treatment–New Jersey, 1992–1999. Morbidity and Mortality Weekly Report, 50(19), 378–381. [Available at www.cdc.gov/mmwr/preview/mmwrhtml/mm5019a2.htm#fig2] Valdiserri, R. (2013, June 6). Hepatitis C infection among young injection drug users: Addressing an emerging trend. http://blog.aids.gov/2013/06/hepatitis-c-infection-amongyoung-injection-drug-users-addressing-an-emergingtrend.html. Centers for Disease Control and Prevention. (2011, May 6). Hepatitis C virus infection among adolescents and young adults–Massachusetts, 2002–2009. Morbidity and Mortality Weekly Report, 60(17), 537–541. [Available at www.cdc.gov/mmwr/preview/mmwrhtml/mm6017a2.htm]

Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention. (n.d.). Viral hepatitis surveillance, United States, 2010. www.cdc.gov/hepatitis/Statistics/2010Surveillance/PDFs/2010H epSurveillanceRpt.pdf.

Quinless, S., Allread, V., & Treisman, G. (2013, December). Injecting drug use trends in New Jersey. New Jersey AIDSLine. www.state.nj.us/health/aids/documents/aidslinedec13.pdf.

Sutor, L., Texas Medical Association. (n.d.). Report of Council on Scientific Affairs. JCAHO Pain Rating Standards. www.texmed.org/Template.aspx?id=5788.

Mularski, R. A., White-Chu, F., Overbay, D., Miller, L., Asch, S. M., & Ganzini, L. (2006, June). Measuring pain as the 5th vital sign does not improve quality of pain management. Journal of General Internal Medicine, 21(6), 607–612.

Fenton, J. J., Jerant, A. F., Bertakis, K. D., & Franks, P. (2012, March). The cost of satisfaction: A national study of patient satisfaction, health care utilization, expenditures, and mortality. Archives of Internal Medicine,172(5), 405–411.

Smith, M. (2012). Black market for prescription pain killers–The real killer. Burning Tree Ranch. www.burningtreeranch.com/black-market-prescription-pain-killers-thereal-killer. See also, Adams, S. (2013, August 16). Florida pain victims trapped by prescription crackdown. Bloomberg News. www.businessweek.com/news/2013-08-16/floridapain-victims-trapped-by-prescription-crackdown-health.

Kitchenman, A. (2013, October 18). Lawmakers begin to shape battle plan for fight against opioids and heroin. NJ Spotlight. www.njspotlight.com/stories/13/10/17/legislators-begin-to-shape-battle-plan-for-fight-against-spread-ofopioids-and-heroin.

McLellan, A. T., Cacciola, J. C., Alterman, A. I., Rikoon, S. H., & Carise, D. (2006). The addiction severity index at 25: Origins, contributions and transitions. The American Journal on Addictions, 15, 113–124.

SAMHSA, Center for Integrated Health Solutions, HRSA, National Council for Community Behavioral Healthcare. (2013, May). Innovations in addictions treatment, addiction treatment providers working with integrated primary care services. www.integration.samhsa.gov/clinicalpractice/13_May_CIHS_Innovations.pdf.

Meyer, J. P., Althoff, A. L., & Altice, F. L. (2013, November). Optimizing care for HIV-infected people who use drugs: Evidence-based approaches to overcoming healthcare disparities. Clinical Infectious Diseases, 57(9), 1309–1317.

Burr, C. K., Storm, D. S., Hoyt, M. J., Dutton, L., Berenzy, L., Allread, V., & Paul, S. (2014). Integrating health and prevention services in syringe access programs: A strategy to address unmet needs in a high-risk population. Public Health Reports, 129(S1), 26–32.

New Jersey Department of Health, Public Health Services Branch, Division of HIV, STD and TB Services. (2013). New Jersey HIV/AIDS report, December 31, 2012. www.state.nj.us/health/aids/documents/qrt1212.pdf. Kaiser Family Foundation. (2011). Estimated numbers of AIDS diagnoses among adults and adolescents, by transmission category, cumulative through 2011. State Health Facts. http://kff.org/state-category/hivaids.

New Jersey Department of Health, Public Health Services Branch, Division of HIV, STD and TB Services. (2013). New Jersey HIV/AIDS report: June 30, 2013. www.state.nj.us/health/aids/documents/hiv_aids_report_2013.pdf.

Department of Human Services, Division of Addiction Services. (2008). HIV/AIDS and substance abuse. www.state.nj.us/humanservices/das/treatment/hiv.

Mortality Weekly Report, 60(43),1487–1492. [Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm]

Tempalski, B., Leib, S., Cleland, C. M., Cooper, H., Brady, J. E., & Friedman, S. R. (2009, January). HIV prevalence rates among injection drug users in 96 large U.S. metropolitan areas, 1992–2002. Journal of Urban Health. 86(1), 132–154. [Available at www.ncbi.nlm.nih.gov/pmc/articles/PMC2629516/] Centers for Disease Control and Prevention. (2011, November 4). Vital signs: Overdoses of prescription opioid pain relievers–United States, 1999–2008. Morbidity and

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By Michael C. Schweder This fall campaign season in New Jersey finds the activities of our politicians and their staff in full swing. This is especially true for U.S. Senator Cory Booker and every member of New Jersey’s U.S. congressional delegation. On November 4, 2014, the general elections will determine if all of their hard work and determination were worth the effort. The 2013 general election featured races for every seat in the state legislative branch. That election resulted in the final makeup of 40 state Senators (24 Democrats/16 Republicans) and 80 General Assembly members (48 Democrats/32 Republicans). Even the executive branch was campaigning for votes. This year, the focus shifts from our state government officials to our national representatives in Washington, DC. The 2014 elections mark the culmination of months of hard work by Democrats and Republicans jockeying to pick up a seat in one of the 12 U.S. congressional districts (CDs). In addition to these races, the winner of last year’s special election, U.S. Senator Booker, is seeking reelection for his short first term. In 2011, the realignment of the legislative districts (LDs) put more emphasis on winning the primary elections in order to secure the party nomination. More often than not, the incumbent party’s primary victors win the general election; the Democrats hope CD12 will be a prime example with U.S. Congressman Rush Holt (D) announcing his retirement after eight terms in office. CD12 had a very challenging primary election, with state Assemblywoman Bonnie Watson-Coleman (D-Mercer) edging out another veteran female lawmaker, State Senator Linda Greenstein (D-Middlesex), as well as Assemblyman Upendra Chivukula (D-Somerset). In the general election, Assemblywoman Watson-Coleman will have to defeat her opponent Alieta Eck, MD (R-Somerset). If successful, Assemblywoman Watson-Coleman would

MDADVISOR | FALL 2014

become the first African American Congresswoman in New Jersey history. In CD3, the Republicans find themselves in a similar predicament as their counterparts in CD12; they hope to fill the vacancy left by the retirement of U.S. Representative Jon Runyan (R-Burlington). It will be difficult to replace the name recognition of the former Eagles star, but the Republicans believe they have a very strong candidate in Randolph Mayor and businessman Tom 1 MacArthur (R-Burlington). MacArthur’s campaign squares him off against attorney and Burlington County Freeholder Amy Belgard (D-Burlington). This district favors Republicans, and many believe MacArthur will hold on with a decisive victory.2 U.S. Representative Rob Andrews (D-CD1), who resigned in February, will be replaced through a special election to be held in November at the same time as the general election. Residents in this congressional district will have been without a representative for nine months at the time of the election.3 The Democrats and Republicans had interesting primaries for the Burlington, Camden and Gloucester county race. The two primary winners were New Jersey State Senator Donald Norcross (D) and another former Eagle and current radio talk show host, Gary Cobb (R). It is widely believed that Senator Norcross has a significant advantage due to CD1’s overwhelming Democratic demographic.4 In the U.S. Senate race, Senator Cory Booker is seeking a full second term in his reelection bid against his conservative challenger, Jeff Bell (R). An early August Quinnipiac University election poll proclaimed a 10-point advantage for the former Newark Mayor.5 With a campaign war chest of approximately $3 million6 and an advantage in name recognition, Senator Booker is poised to retain control of his Senate seat.7

“If successful, Assemblywoman Watson-Coleman would become the first African American Congresswoman in New Jersey history.”

In one of the last competitive races, Congressman Frank LoBiondo is seeking reelection against attorney Bill Hughes, Jr. (D), in Congressional District 2. Hughes is an interesting opponent for Representative LoBiondo because he is the son of former Congressman Bill Hughes. In all the other congressional races, the outcome has been predicted to favor the incumbents: Congressman Chris Smith (R) in CD4, Congressman Scott Garrett (R) in CD5, Congressman Frank Pallone (D) in CD6, Congressman Leonard Lance (R) in CD7, Congressman Albio Sires (D) in CD8, Congressman Bill Pascrell (D) in CD9, Congressman Donald Payne, Jr. (D), in CD10 and Congressman Rodney Frelinghuysen (R) in CD11. HOT TOPIC LEGISLATION Earlier this year, Governor Chris Christie signed into law Senate Bill S-792. S-792 is an important piece of legislation for women because it “requires insurers to cover breast evaluations and other additional medically necessary testing under certain circumstances and requires certain mammogram reports to contain information on breast density.”8 This legislation survived the Governor’s conditional veto that so many other health-related bills did not. S-792 was supported by radiologists, but it was “opposed by obstetricians, who said it would lead to unnecessary tests to head off lawsuits.”9 Michael C. Schweder is the Director of Government Affairs at Cammarano, Layton & Bombardieri Partners, LLC, in Trenton, New Jersey. 1

Levinsky, D., & Camilli, D. (2013, November 8). Runyan won’t seek 2014 re-election; Belgard enters race. Burlington County

Times. www.burlingtoncountytimes.com/news/local/sourcesrunyan-won-t-seek-re-election-in/article_57116c76-5e03522e-a2ba-2751ce03aa7d.html. 2

Pizarro, M. (2014, June 18). CD3 setpiece: MacArthur versus Belgard. PolitickerNJ. www.politickernj.com/74706/cd3setpiece-macarthur-versus-belgard.

Mutnick, A. (2014, August 10). Rep. Rob Andrews’ resignation legislation in limbo. MyCentralJersey.com. www.mycentraljersey.com/story/news/local/new-jersey/2014/08/10/reprob-andrews-resignation-leaves-train-safety-legislationlimbo/13859453

Johnson, B. (2014, June 3). 1st congressional district: Norcross to face ex-Eagles player. The Star-Ledger. www.nj.com/ politics/ index.ssf/2014/06/1st_congressional_district_norcross_to_ face_ex-eagles_player.htm.

Quinnipiac University. (2014, August 6). Clinton blooms over Christie in Garden State, Quinnipiac University poll finds; Booker tops little-known challenger by 10 points. Quinnipiac University Poll. www.nj.com/politics/index.ssf/2014/06/1st_ congressional_ district_norcross_to_face_ex-eagles_player.html.

Bonamo, M. (2014, August 5). U.S. senate race: Senior Christie adviser Palatucci vows fundraising help for Bell. PolitickerNJ. www.politickernj.com/78686/us-senate-racesenior-christie-adviser-palatucci-vows-fundraising-help-bell.

Zernike, K. (2014, June 4). In New Jersey, a Republican nominee will try to hold on to a congressional seat. The New York Times. www.nytimes.com/2014/06/04/nyregion/ in-new-jerseya-republican-nominee-will-try-to-hold-on-to-a-congressionalseat.html?_r=0.

State of New Jersey. (n.d.). Senate No. 792. www.njleg.state.nj.us/2012/Bills/S1000/792_R6.HTM.Press.

Kitchenman, A. (2014, January 22). Christie’s ‘pocket veto’ kills bill requiring health workers to get flu shots. NJSpotlight. www.njspotlight.com/stories/14/01/21/christie-s-pocket-vetokills-bill-requiring-health-workers-to-get-flu-shots/.

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A REMINDER THAT

PUBLIC HEALTH IS

GL BAL: New Jersey Monitoring for Emerging Communicable Diseases

By Commissioner Mary E. O’Dowd, MPH

hile the Ebola outbreak in West Africa has captured the world’s attention, the severity of this outbreak is shining a light on the importance of having a strong public health system to combat communicable diseases–both common and emerging. Although many of the diseases we face are not as deadly as Ebola, they all require close surveillance, preparedness and prevention to protect our residents. With advances in transportation, diseases that were never seen in the United States have the potential to become established in our country (as recent outbreaks of measles imported by travelers have shown). Fortunately, a comprehensive system is in place for monitoring the spread of disease that includes local, state and national health officials and the Center for Disease Control and Prevention’s (CDC’s) 20 quarantine stations. New Jersey healthcare providers who stay alert to the signs and symptoms of travel-related illnesses and follow disease prevention protocols are an additional key factor in containing the spread of these infectious diseases.

infected mosquito. Most patients feel better after a few days or weeks; however, some people may develop longterm effects.2 Although the chikungunya virus is not contagious from person to person, newly infected patients should be instructed to avoid contact with mosquitos for one week following symptom onset to reduce the chances of transmitting the virus to local mosquito population. There is currently no vaccine or medication to prevent or treat chikungunya virus. Those affected can decrease symptoms by getting plenty of rest, drinking fluids to prevent dehydration and taking medicines such as ibuprofen, naproxen or acetaminophen to relieve fever and pain. The Department is monitoring chikungunya closely, and the Public Health and Environmental Laboratory has begun testing mosquitos for chikungunya as part of our surveillance system. This testing will help identify whether this disease has been transmitted to our local mosquito populations.

CHIKUNGUNYA VIRUS Local transmission of chikungunya virus (which is transmitted by mosquitos) was identified in the Americas in Caribbean countries and territories in 2013.1 Chikungunya outbreaks have occurred in countries in Africa, Asia, Europe and the Indian and Pacific Oceans. Then, in July 2014, the United States saw the first locally-acquired cases of chikungunya in Florida. At this time, New Jersey has seen only travel-related cases of chikungunya. The majority of these 87 cases traveled to the Dominican Republic. Infection with chikungunya virus is rarely fatal, but the joint pain the virus causes can often be severe and debilitating. Other symptoms include high fever, headache, muscle pain, back pain and rash. Symptoms appear on average three to seven days after the individual is bitten by an

MIDDLE EAST RESPIRATORY SYNDROME (MERS) During 2014, the United States experienced its first imported cases of Middle East Respiratory Syndrome (MERS), which is caused by a virus and impacts the respiratory system. In May 2014, the CDC confirmed two unlinked imported cases of MERS in the United States–one to Indiana, the other to Florida. Both cases were found in healthcare providers who lived and worked in Saudi Arabia. Both traveled to the United States from Saudi Arabia, where it is believed they were infected. These individuals were hospitalized in the United States and later discharged.3 Health officials first reported the disease in Saudi Arabia in September 2012. Through retrospective investigations, it was determined that the first known cases of MERS occurred in Jordan in April 2012. Thus far, all cases

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of MERS have been linked to countries in and near the 4 Arabian Peninsula. There have been no cases of MERS in New Jersey, and according to the CDC, MERS represents a very low risk to the U.S. general public. Most people confirmed to have MERS infection have had severe acute respiratory illness with symptoms of fever, cough and shortness of breath. Some have also had gastrointestinal symptoms including diarrhea, nausea 5 and vomiting. The illness has spread through close contact from ill people to others, such as those caring for or living with an infected person. Infected people have spread the virus that causes MERS (MERS-CoV) to others in healthcare settings, such as hospitals. Researchers studying MERS have not seen any ongoing spread of MERS-CoV outside the healthcare setting.6 CDC has created a webpage on MERS for healthcare providers; this page outlines guidance and offers a checklist that providers can use to evaluate patients for MERS. It is available at: www.cdc.gov/coronavirus/mers/hcp.html. EBOLA Although Ebola virus cases have occurred in Africa dating back to 1976, the ongoing outbreak in West Africa is the largest and most complex ever documented.7,8 The CDC has stated that Ebola is not viewed as a significant danger to the United States because it is not transmitted easily, does not spread from people who are not ill and we know how to stop Ebola with strict infection control practices, which are already in widespread use in American hospitals.8 At this time, there are no cases of Ebola in the United States, with the exception of two U.S. healthcare workers who were infected with Ebola virus in Liberia and were transported to a hospital in the United States. Both have since been discharged from the hospital. The Department has worked with several healthcare providers to evaluate individuals with travel history to West Africa and asks that providers stay alert. All persons with suspect travel history and compatible symptoms (which include fever, headache, stomach pain, diarrhea and vomiting) should be isolated until clinical evaluation and/or diagnostic testing is completed. Confirmed or suspected cases of any viral hemorrhagic fever, including Ebola, should be reported immediately to the local health department where the patient resides. The Department has developed a significant number of materials and tools for healthcare providers that

include information on symptoms, infection control and case definitions that are available on our Ebola webpage at http://nj.gov/health/cd/vhf/. PROVIDER PREPAREDNESS The Department of Health has a well-established relationship with our healthcare providers and with our local health officials who are very experienced in monitoring and preventing the spread of disease. Our healthcare facilities have infection prevention programs and are ready to deal with potential infectious patients who come through their doors on any given day. This preparedness was demonstrated in August 2014, when the staff at CentraState Medical Center treated an individual who had recently traveled to West Africa and arrived at the emergency room via ambulance with flu-like symptoms; this person became a “patient under investigation.” CentraState, as a precautionary measure, implemented its infectious disease protocols during the patient’s transport to and arrival at the hospital–including using an isolation room specifically designed for infectious patients. After consultation with the CDC, it was determined that the patient, despite recent travel history to West Africa, had no 9 known exposure to Ebola, and the patient was discharged. This is an example of the system working well. Although our hospitals are well-prepared, it is important to stay vigilant and informed on diseases that pose a risk to travelers; viruses can be unpredictable. Providers should remind staff of the importance of travel history during the triage and initial medical exams so that cases can be identified quickly before patients potentially expose others throughout the healthcare facility. Since New Jersey is one of the most diverse states in the nation, healthcare workers in this state need to be on high alert to suspect cases of imported disease and take infection control actions immediately in individuals with travel history and symptoms. As always, if providers have a suspect case of any reportable diseases, it is critical that public health officials are immediately notified, ensuring that necessary resources such as laboratory personnel and epidemiologists are engaged and ready to assist should the need arise. These steps are essential for preventing the spread of disease. Global migration has been the pathway for disseminating infectious diseases throughout recorded history and will continue to shape the emergence, frequency and spread of infections in geographic areas and populations. Today, the

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current volume, speed and reach of travel are unprece10 dented, and so it is natural to be anxious when dealing with diseases that are new to the United States. However, it is important to ensure that the potential fear is converted into appropriate and compassionate behaviors. For example, it is critical that patients with travel history are managed with appropriate and meticulous infection control measures but also with compassion for their situation and individual fear.

CDC

As healthcare providers, you are on the frontlines; your identification of disease is paramount to reducing disease spread. The Department will continue to share information on these diseases with you through its website at www.nj.gov/health. The Department continues to share information via our New Jersey Local Information Network and Communication Systems (LINCS) alert system. Healthcare providers can receive alerts by creating an account at http://njlincs.net/.

Ready 24/7 to Respond to Ill Travelers

By Racquel Williams, MPH, REHS, Assistant Officer in Charge LCDR, U.S. Public Health Service, CDC Newark Quarantine Station, Newark Liberty International Airport As the Centers for Disease Control and Prevention (CDC) and the international public health community work to bring the Ebola outbreak in West Africa under control, the CDC’s quarantine staff in the United States is ready 24/7 to respond to ill travelers who enter the country. In 2013, more than 5.5 million international travelers–about 15,000 a day–arrived at Newark Liberty International Airport, the home of one of the CDC’s 20 quarantine stations in the United States. Though not always noticeable, the CDC is constantly monitoring arriving travelers for signs of infectious diseases at U.S. airports, seaports and land borders through an important network of critical partners who serve as our “eyes and ears.” Staff in the Newark Quarantine Station work closely with Customs and Border Protection, emergency medical service units, hospitals, state/local health departments and the Port Authority of New York and New Jersey to prevent

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and prepare for the introduction and spread of infectious diseases. In addition, airlines, cruise lines, cargo ships and Customs and Border Protection officers (who conduct passport review for all arriving travelers) receive regular guidance from the CDC on detecting and reporting suspected cases of communicable diseases to CDC quarantine stations. Across all 20 quarantine stations, public health officers make about 2,000 health consultations each year. The work we do to protect our nation would not be possible without this critical network of partners. The CDC and its partners particularly focus on preventing the spread of quarantinable communicable diseases, including viral hemorrhagic fevers (like Ebola), cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever, severe acute respiratory syndromes and novel flu viruses that are causing or could cause a pandemic. We also focus on highly contagious diseases, such as measles, that are uncommon in the United States, but

circulating elsewhere, and on serious infections such as meningococcal disease that can be prevented by quickly providing medications to sick people. For more information about travel-related diseases and the latest CDC travel notices, visit the following CDC websites: Travelers’ Health: www.cdc.gov/travel Clinician updates: wwwnc.cdc.gov/ travel/page/clinician-updates. (This is an excellent website for providers to stay informed about diseases such as chikungunya and Ebola, as well as others such as malaria, dengue and measles that pose a risk to travelers.) Yellow Book: wwwnc.cdc.gov/travel/ yellowbook/2014/table-of-contents (This site offers a wealth of information on travel-related disease that would be helpful to physicians evaluating patients.) Quarantine Stations: www.cdc.gov/ quarantine/quarantinestations.html Quarantine and Isolation Information: www.cdc.gov/quarantine/

We ask that all providers review information on these diseases, remember key disease prevention protocols and stay alert for those with symptoms. We also remind providers to report notifiable communicable diseases promptly to their local health departments because these conditions could 11 pose a threat to the community. Working together, we can increase our preparedness and protect our residents from infectious disease. Mary E. O’Dowd, MPH, is the Commissioner of the New Jersey Department of Health. 1

Centers for Disease Control and Prevention. (2014, May 16 [updated]). Middle East Respiratory Syndrome. Symptoms & Complications. www.cdc.gov/coronavirus/MERS/about/symptoms.html.

Centers for Disease Control and Prevention. (2014, May 16 [updated]). Middle East Respiratory Syndrome. Transmission. www.cdc.gov/coronavirus/MERS/about/transmission.html.

World Health Organization. (2014, April [updated]). Ebola virus disease fact sheet No. 103. www.who.int/mediacentre/factsheets/fs103/en/.

Centers for Disease Control and Prevention. (2014, August 26 [updated]). Geographic distribution. Chikungunya. www.cdc.gov/chikungunya/geo/index.html.

Frieden, T. R. (2014, August 7). Combating the Ebola threat. www.cdc.gov/washington/testimony/2014/t20140807.htm.

Centers for Disease Control and Prevention. (2014, March 26 [updated]). Symptoms, diagnosis & treatment. Chikungunya. www.cdc.gov/chikungunya/symptoms/index.html.

Mackesy, R. (2014, August 7). 8/7/2014: Health news update. www.centrastate.com/News/HealthNewsUpdate862014?showBack=true&PageIndex=0.

Centers for Disease Control and Prevention. (2014, June 20 [updated]). Middle East Respiratory Syndrome (MERS). MERS in the U.S. www.cdc.gov/coronavirus/mers/US.html.

Wilson, M. E. (1995, April-June). Travel and the emergence of infectious disease. Emerging Infectious Diseases, 1(2), 39–46. [Available at wwwnc.cdc.gov/eid/article/1/2/pdfs/95-0201.pdf]

State of New Jersey Department of Health. (2014). Disease reporting requirements/regulations. Communicable Disease Service. www.nj.gov/health/cd/reporting.shtml.

Centers for Disease Control and Prevention. (2014, June 4). Middle East Respiratory Syndrome (MERS). About MERS. www.cdc.gov/coronavirus/MERS/about/index.html.

“S

ince New Jersey is one of the most diverse states in the nation, healthcare workers in this state need to be on high alert to suspect cases of imported disease and take infection control actions immediately in individuals with travel history and symptoms.” MERS

CHIKUNGUNYA VIRUS

NJ INDIANA

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The

Evolution

Fibromyalgia IN MODERN AMERICA*

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* Portions of this article were first published in Perspectives in Biology and Medicine 54.4 (2011), 417â&#x20AC;&#x201C;437. Reprinted with permission by Johns Hopkins University Press. Copyright 2011 by The Johns Hopkins University Press.

By Gerald N. Grob, PhD “To some, the syndrome is ‘an age-old malady begging for 2

respect.’ To others it is a form 3

of ‘labeling woefulness.’ Although, today, the diagnosis cuts across a variety of medical specialties, including (but not limited to) rheumatology, psychiatry and internal medicine, only a few decades ago, FM (and its predecessor fibrositis) was of little interest or concern either to physicians or the general public.”

Today, at the beginning of the 21st century, fibromyalgia syndrome (FM) has become a diagnostic category that includes an extremely large number of people, predominantly women. Estimates that perhaps 2 to 4 percent of the adult population suffers from FM have been widely accepted. Patients diagnosed with FM incur substantial medical costs as well as high rates of disability. Yet the diagnosis has remained highly contested; there are competing etiological theories and therapies, to say nothing about an extraordinarily weak evidentiary foundation. Indeed, a leading authority has identified what he calls the “fibromyalgia wars.”1 To some, the syndrome is “an age-old malady begging for respect.”2 To others, it is a form of “labeling woefulness.”3 Although, today, the diagnosis cuts across a variety of medical specialties, including (but not limited to) rheumatology, psychiatry and internal medicine, only a few decades ago, FM (and its predecessor fibrositis) was of little interest or concern either to physicians or the general public. It is instructive for the medical community to consider at this point in time the evolution of FM: What were the origins of the FM diagnosis? Why did its boundaries expand so rapidly during and after the 1980s? The answers to such questions are complex, embedded in broad social and intellectual currents, internal developments within medicine and the rise of an increasingly important pharmaceutical industry that all converged to elevate the importance of FM. ORIGINS OF THE DIAGNOSIS The origins of the FM diagnosis are complex. Pain, as well as related symptoms such as chronic fatigue, weakness, irritability, anxiety and depression, has always been part of the human experience and often occurs along a continuum without sharply divided boundaries. In many

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instances, pain results from pathological conditions. In others, it is related to the somatization following stressful events. Often pain cannot be explained in either pathological or psychological terms, yet individuals experiencing such pain demand explanations and frequently seek medical or other assistance to alleviate their distress. In the 1920s and after, with the emergence of rheumatology as a specialty dealing with the musculoskeletal system, the debate over the pathogenesis and nature of fibrositis assumed a new form. Whereas, Western biomedicine sought to trace pain back to an underlying organic condition, rheumatologists dealt with pain as a subjective experience of the patient. The specialty lacked a coherent conceptual framework, its therapies were of doubtful efficacy and there was little agreement on diagnostic categories. Thus, unproven theories and speculative explanations proliferated. (This is not to say that rheumatology differed from many other specialties; on the contrary, the same was true of much of medicine.) In the three decades following World War II, fibrositis occupied a distinctly minor niche in medical nosology. In 1975, Harvey Moldofsky and others published a famous sleep study involving 10 individuals in which they proposed that the fibrositis symptom complex was a “non-restorative 4 sleep syndrome.” Two years later, Hugh Smyth and Moldofsky suggested that fibrositis was indeed a definable entity that could be identified by exaggerated tenderness at anatomically reproducible locations or “trigger points.”5 THE RISE OF A PREOCCUPATION WITH FM During and after the 1980s, a fundamental shift in the boundaries of the diagnosis, as well as of public perceptions of FM (the term that succeeded fibrositis), became evident. Nowhere was this better illustrated than by the number of articles on the diagnosis published in PubMed. Between 1959 and 1979, 336 articles on fibrositis appeared; from 1980 to 1990, the number rose to 442. Thereafter, a flood of literature followed. In the 1990s, no fewer than 1,700 articles appeared, and the number rose to more than 2,700 in the first decade of the 21st century. A significant proportion, however, were review articles, editorials and commentaries, rather than the results of original research that confirmed FM’s legitimacy or boundaries. So what accounts for the rising preoccupation with FM during and after the 1980s? The expansion of the FM diagnosis was shaped by a variety of external and internal determinants. During the

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second half of the 20th century, many aspects of life became medicalized. The care and treatment of the sick and infirm remained an integral part of medicine, but to this was added the medicalization of social and personal problems. It is clear that the professional expansion of rheumatology and other specialties played a role in this process, but other forces were equally clear. A consumer culture and the rise to prominence of the pharmaceutical industry fueled a faith that interventions capable of preventing and treating disease were readily available. Equally, if not more, important was the rise of a powerful women’s movement during and after the 1960s. Because women constituted between 75 and 88 percent of the total diagnosed with FM in clinical settings, rheumatologists avoided explanations that made an association between women and FM in terms of biology (sex) or in terms of culture (gender). Using non-gendered, biomedical language enabled rheumatologists to avoid a psychosomatic interpretation that rested on a belief in the innate biological inferiority of women. In this way, they 6 did not incur the ire of feminist activists. The heightened interest in FM was by no means a novel development. Interest in medically unexplained symptoms cut across a growing number of specialties during these years. As three British researchers observed, such symptoms could be “presentations of recognized psychiatric disorders such as anxiety or depression; a part of operationally unexplained syndromes such as chronic fatigue syndrome, irritable bowel syndrome or fibromyalgia.”7 THE AMERICAN COLLEGE OF RHEUMATOLOGY AND FM Although Moldofsky’s sleep study4 and Smythe’s emphasis on tender points in reproducible locations5 clearly stimulated medical interest in FM, the absence of an accurate case definition–a clear set of criteria that would include people with the illness and exclude those without it–presented formidable difficulties. During the 1980s, teams led by such leading fibromyalgia researchers as Frederick Wolfe, Robert M. Bennett, Don L. Goldenberg, Muhammad Yanus and Timothy C. Payne developed their own criteria. Each had the possibility of creating reliability, which would enable physicians to agree on the diagnosis.8 The validity of the diagnosis, however, lacked any evidentiary foundation. The absence of unanimity on the criteria and the fact that different

populations were used only compounded the difficulties of conducting research on FM. In 1986, therefore, a consortium of centers dealing with patients diagnosed with FM–with support from Merck, Sharpe and Dohme, Inc.–created a committee to determine the criteria for diagnosing primary and secondary FM. The study had four specific objectives: 1) to provide a consensus definition of FM, 2) to establish new criteria for its classification, 3) to study the relationship between primary and secondary FM and 4) to ascertain how well previous criteria sets worked in a multi-center data set and to establish their relationship to 9 the new criteria. Tender points, the committee reported, were “the most powerful discriminator between fibromyalgia patients and controls.” Tenderness, using patients’ responses of “mild or greater” provided “the most discriminating power.”9 The criteria of the American College of Rheumatology (ACR) included a history of widespread pain and pain in 11 of 18 tender point sites on digital palpation. Sleep disturbances, fatigue and stiffness were “central symptoms,” and each was present in more than 75 percent of patients given the FM diagnosis. Nevertheless, the simultaneous presence of these three symptom groups was not required.9 The creation of a numerical scale to measure tender points as part of the diagnostic process was not unique to FM. In the last half of the 20th century, numbers and scales were increasingly used as diagnostic mechanisms. The use of numerical scales (which were constantly shifting), especially when wedded to a sophisticated technology, had given medicine an aura of certainty and precision. The adoption of a numerical scale in the diagnostic criteria for FM strengthened the legitimacy of FM. The legitimization of FM had significant consequences. Formalizing a diagnosis–a process supported by Merck, Sharpe and Dohme, Inc.–enhanced the pharmaceutical industry’s ability to market drugs. During the 1990s, the sales of psychiatric drugs to patients given the FM diagnosis grew rapidly. By the beginning of the 21st century, such new drugs as progabalion (Lyrica) and duloxetine (Cymbalta) had come to market. Given U.S. Food and Drug Administration (FDA) approval, extensive directto-consumer advertising and pharmaceutical industry funding for symposia at medical meetings as well as for medical leaders who wrote studies published in medical journals, it was hardly surprising that the sales of such

drugs surged. In 2011, sales of Lyrica and Cymbalta were 10 $3.7 and $3.1 billion, respectively. Advertisements for these drugs were often misleading and, at worst, false, but they served to recruit patients with transitory pain.1 THE PERSISTENCE OF AMBIGUITY Formalizing a diagnostic syndrome, together with the adoption of a numerical scale, however, did little to quiet the disarray that was characteristic of discussions dealing with FM. Nowhere was this better illustrated than in the numerous publications by Frederick Wolfe, arguably the most important figure in FM research. Although hopeful that the criteria established by the American College of Rheumatology (ACR) would lead to a more uniform definition of FM,11 he became increasingly skeptical about the tendency to define FM as a discrete disease, to say nothing about the uses to which the diagnosis was being put. Wolfe did not deny that a pool of patients were experiencing pain, but he also emphasized the many uncertainties of the diagnosis. By 2003, he had concluded that the ACR criteria emphasizing tender points were a mistake. That criterion

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ignored the psychosocial and distress features of FM and chose a physical exam, suggesting it was a physical dis12 ease. The formalization of the disease, he observed, resulted in a dramatic expansion of the number of patients diagnosed with disease and exposed to new treatments of questionable efficacy.1 The expansion of the FM diagnosis also had important economic consequences. By the mid-1990s, nearly a quarter of the patients diagnosed with FM were receiving some type of disability payments, including 15 percent from Social Security.13 In a seven-year prospective study, Wolfe, Robert M. Bennett, Don L. Goldenberg, Muhammad Yanus and four others–all leading figures–found that those diagnosed with FM incurred high medical costs. In 1996, the yearly cost per patient was $2,274. Patients averaged 10 outpatient medical visits per year and were hospitalized once every three years. The outcomes, they noted, were “uniformly poor.”14 “Should we not admit our ignorance,” editorialized two Harvard Medical School physicians. “A patient should feel supported, but until an understanding of the pathophysiology of fibromyalgia yields more effective therapy, continued medical follow-up may be futile and costly.”15 In the 1990s, the debate over FM became even more complex and controversial as its boundaries grew even wider. During this decade, a large number of studies focused on the comorbidity of FM with a variety of other medical and psychiatric disorders, including migraine, irritable bowel syndrome, chronic fatigue syndrome and major depression, anxiety and mood disorders. There were numerous investigations of the role of hormones, neurotransmitters, abnormal sensory processing, aberrant central pain mechanisms and central nervous system metabolism, to cite only a few examples. The inability to differentiate FM from similar disorders proved frustrating, and disagreements were common. In 2008, Yanus proposed that central sensitivity syndromes (CSS) were the appropriate nosology for a variety of conditions, including FM. He also rejected the disease-illness dualism; illnesses in his eyes were diseases as well.16 In contrast, Wolfe continued to distinguish between illness (“a biocultural term that implies social construction”) and disease (“a biomedical term”). Diagnosing FM as a disease, he believed, did more harm than good. His advice was simple: “You have a kind of pain problem that we commonly see but that doctors do not understand well. There is a lot we can do to help you. . . . Some doctors call your

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problem FM. FM is the name we give to such problems, 1 not the cause of the problems.” The act of giving a name to symptoms and disability, echoed Simon Wessely, “brings relief.” Used “constructively and appropriately, it is the first step toward recovery.”17 THE UNANSWERED QUESTION Recent developments have done little to resolve the many unanswered issues posed by the FM diagnosis. Twenty years after the criteria for classifying FM were issued, the ACR adopted new criteria. The new guidelines removed tender points as the central element in the FM definition, changed the case definition of FM, created the widespread pain index (WPI) and provided a system severity scale (SS).18 In the somewhat ambivalent words of Wolfe (who was deeply involved in the process), “One can now study fibromyalgia and fibromyalgianess without the requirement for belief in its existence.”19 Treatment recommendations were equally eclectic and included pharmacological and nonpharmacological (education, cognitive behavioral therapy and exercise) therapies. In a recent clinical review, Daniel J. Clauw noted that FM could be conceptualized as a “centralized pain state” in which centralized referred to “central nervous origin of or amplification of pain.” Genetic and environmental factors, psychological, behavioral and social issues were all involved in pathogenesis.20 Indeed, the diversity of subjective symptoms among patients with the FM diagnosis led the Canadian Fibromyalgia Guidelines Committee to conclude that all of the many therapeutic approaches failed to result in a meaningful measure of clinical outcome.21 The history of FM reveals much about modern American medicine. Fibrositis–a diagnostic category given its name by Sir William Gowers in 1904–remained a relatively obscure entity that affected few persons. FM, a diagnosis that replaced fibrositis during the 1980s, in the beginning was equally obscure and lacked biopathology. The development of the ACR criteria in 1990 and modification in 2010, however, gave FM legitimacy even though it lacked biopathology. At that point, the confluence of a series of developments–the emergence of rheumatology, the medicalization of everyday life problems, ACR diagnostic criteria, the pharmaceutical industry’s ability to market drugs and the ultimate formalization and expansion of the disease–resulted in a dramatic increase in the numbers of persons diagnosed with FM. Yet the amorphous nature

of the FM diagnosis and its ever-shifting boundaries continued to pose challenges to medical practice. Gerald N. Grob, PhD, is Henry E. Sigerist Professor of the History of Medicine, Emeritus, Rutgers University. 1

Wolfe, F. (2009). Fibromyalgia wars. Journal of Rheumatology, 36, 671–678.

Powers, R. (1993). Fibromyalgia: An age-old malady begging for respect. Journal of General Internal Medicine, 8, 93–105.

Hadler, N. M. (2005). The social construction of fibromyalgia. Spine, 30, 1–4.

https://investor.lilly.com/releasedetail2.cfm?releaseid= 643979. 11

Wolfe, F. (1990). Fibromyalgia. Rheumatic Disease Clinics of North America, 16, 681–698.

Wolfe, F. (2003). Stop using the American College of Rheumatology criteria in the clinic. Journal of Rheumatology, 30, 1671–1672.

Wolfe, F., & Potter, J. (1996). Fibromyalgia and work disability: Is fibromyalgia a disabling disorder? Rheumatic Disease Clinics of North America, 22(2), 369–391.

Wolfe, F., Anderson, J., Harkness, D., Bennett, R. M., Caro, X. J., Goldenberg, D. L. . . . Yanus, M. B. (1997). A prospective longitudinal, multicenter study of service utilization and costs in fibromyalgia. Arthritis and Rheumatism, 40, 1560–1570; Wolfe, F., Anderson, J., Harkness, D., Bennett, R. M., Caro, X. J., Goldenberg, D. L. . . . Yanus, M. B. (1997). Health status and disease severity in fibromyalgia. Arthritis and Rheumatism, 40, 1571–1579.

Moldofsky, H., Scarisbick, P., England, R., & Smythe, H. (1975). Musculoskeletal symptoms and non-REM sleep disturbance in patients with “fibrositis syndrome” and healthy subjects. Psychosomatic Medicine, 37, 341–351.

Smythe, H., & Moldofsky, H. (1977). Two contributions to understanding of the “fibrositis” syndrome. Bulletin of the Rheumatic Diseases, 28, 929–931.

Barker, K. K. (2005). The fibromyalgia story: Medical authority and women’s world of pain. Philadelphia: Temple University Press.

Solomon, D. H., & Long, M. H. (1997). Fibromyalgia: Scourge of humankind or bane of a rheumatologist’s existence? Arthritis and Rheumatism, 40, 1553–1555.

Yanus, M. (2008). Central sensitivity syndromes: A new paradigm and group nosology for fibromyalgia and overlapping conditions, and the related issue of disease versus illness. Seminars in Arthritis and Rheumatism, 37, 339–352.

Wessely, S. (2002). Letter. British Medical Journal, 324, 912.

Wolfe, F., Clauw, D. J., Fitzcharles, M. A., Goldenberg, D. L., Katz, R. S., Mease, P., Russell, A. S. . . . Yanus, M. (2010). The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care & Research, 62, 600–610.

Wolfe, F. (2010). Editorial: New American College of Rheumatology criteria for fibromyalgia: A twenty-year journey. Arthritis Care & Research, 62, 583–584.

Clauw, D. J. (2014). Fibromyalgia: A clinical review. Journal of the American Medical Association, 311, 1547–1555.

Fitzcharles, M. A., Ste-Marie, P. A., & Pereira, J. X. (2013). Canadian Medical Association Journal, 185, E645–E651.

Nimnual, C., Hotopf, M., & Wessely, S. (2001). Medically unexplained symptoms: An epidemiological study in seven specialties. Journal of Psychosomatic Research, 51, 361–367.

Bennett, R. (1981). Fibrositis: Misnomer for a common medical disorder. Western Journal of Medicine, 134, 405–413; Payne, T. C., Leavitt, F., Garron, D. C., Katz, R. S., Golden, H. E., Glickman, P. B., & Vanderplate, C. (1982). Fibrositis and psychologic disturbance. Arthritis and Rheumatism, 25, 213–217; Yanus, M. (1984). Primary fibromyalgia syndrome: Current concepts. Comprehensive Therapy, 10, 21–28; Wolfe, F. (1988). Fibrositis, fibromyalgia, and musculoskeletal disease: The current status of the fibrositis syndrome. Archives of Physical Medicine and Rehabilitation, 69, 527– 531; Wolfe, F. (1989). The design of a fibromyalgia criteria study. Journal of Rheumatology, 16(suppl. 19), 181–184; Goldenberg, D. L. (1989). Psychiatric and psychologic aspects of fibromyalgia syndrome. Rheumatic Disease Clinics of North America, 15, 105–114.

Wolfe, F., Smythe, H. A., Yanus, M. B., Bennett, R. M., Bombardier, C., Goldenberg, D. L. . . . Schoen, R. P. (1990). The American College of Rheumatology 1990 criteria for the classification of fibromyalgia: Report of the multicenter criteria committee. Arthritis and Rheumatism, 33, 160–172.

Zacks Equity Research. (2012, November 19). Data on Pfizer’s Lyrica. www.zacks.com/stock/news/87159/data-on-Pfizers-Lyrica;

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Building Health

in New Jersey and Beyond:

An Interview with Risa Lavizzo-Mourey, MD, MBA, and Betsy Ryan, Esq. By Steve Adubato, PhD In recent interviews for One-on-One with Steve Adubato, which airs on PBS stations Thirteen/WNET and NJTV, Steve Adubato sat down with Risa Lavizzo-Mourey, MD, MBA, President and CEO of the Robert Wood Johnson Foundation, and Betsy Ryan, Esq., President and CEO of the New Jersey Hospital Association, to discuss initiatives going on in New Jersey and beyond to improve the health of our citizens. This article is an adapted version of those TV interviews. Adubato: What is the Robert Wood Johnson Foundation, and how does it make an impact on healthcare? Lavizzo-Mourey: We are the largest foundation devoted solely to improving health and healthcare in this country, but what we’re really excited about right now is a vision that we have to build a culture of health. We strive to ensure that everyone in this generation and in future generations has the opportunity to lead a healthy life. That is what we’re making our North Star at the Foundation. Adubato: You have been a practicing physician as well as a leader of the Foundation. What is the importance of reversing the childhood obesity epidemic? Lavizzo-Mourey: We know that when kids enter adulthood overweight or obese, they have a much higher probability of getting chronic illnesses like heart disease and diabetes, which leads to disabilities and early death. As a result, we may be raising the first generation that lives sicker and dies younger than their parents. Reversing that trend means creating the opportunity for kids to make healthy choices.

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Adubato: You have stated that part of what you do at the Foundation is to find people who already are doing good work and partner with them. Dr. Jeffrey Brenner is doing great work in Camden. His ground-breaking model is nationally recognized, proving that community-based health is doable. What does the Foundation do to collaborate with Dr. Brenner? Lavizzo-Mourey: Dr. Brenner is a role model for so many people because he was able to show with real data that 5 percent of the patients in Camden were using upwards of 50 percent of the resources. The reason for this was that these patients didn’t have the kinds of services that would keep them out of the hospital–things like transportation, housing and access to prescriptions. Dr. Brenner began looking for different models that could help to provide the services that keep people out of the hospital. The Robert Wood Johnson Foundation helped to provide the kind of funding that he needed to do the analysis and then to provide the resources to connect all of these various providers that needed to come together. And probably the most important thing that we did was to connect him with people like you and others around the country who can tell the story, so others can hear about the great work being done and replicate the model. Adubato: You have said that we need all kinds of leaders to bring our country toward a “culture of health.” Who are these leaders? Lavizzo-Mourey: I am a physician, and I can say that physicians aren’t enough. We need leaders who understand the full continuum of care and how to bring health to where people live, learn, work and play. The Robert Wood Johnson Foundation has been interested for a long time in developing nurses as those kinds of leaders.

“One of the things we found out early on after the Affordable Care Act was enacted was that people didn’t understand the benefits. We also learned that the best way for people to learn about that was one-on-one with people they can trust.”

Risa Lavizzo-Mourey, MD, MBA Betsy Ryan, Esq.

There is a dearth of opportunity for all the capabilities that nurses have, and we are investing in advancing the role that nurses have in healthcare. But it also goes beyond that. So many times, the leaders who can improve the health of a community are people who don’t think of themselves as focusing on health, such as architects, urban planners and educators. The best predictor of a person’s health is educational attainment, so if we can instill in our educational leaders a sense of what they can do to improve the health of their students and ensure that they get higher educational attainment, we will tremendously improve the health of our country. Adubato: How did the Robert Wood Johnson Foundation come to collaborate with the New Jersey Hospital Association in the employment of Veterans to help enroll people in the Affordable Care Act?

Adubato: Why Veterans? Ryan: We have a great pool of candidates who are currently unemployed and who have real-life experience. There’s also the added benefit that about 40 percent of them are bilingual, which is important because New Jersey is a very diverse state. Well over 100 languages are spoken here, and it’s very important to talk to people in the language that they are comfortable with. Adubato: We deal with statistics, and obviously everyone is very interested in how many people have been enrolled. But then again, this all comes down to personal connection. There is that one person who is now enrolled who may not have enrolled if this Veteran had not pushed the issue with her and made that personal connection.

Lavizzo-Mourey: One of the things we found out early on after the Affordable Care Act was enacted was that people didn’t understand the benefits. We also learned that the best way for people to learn about that was one-on-one with people they can trust. We paired that with the fact that we have millions of Veterans who are looking for a way to reengage in their communities, and this was a match that we could envision.

Ryan: These Veterans have touched more than 20,000 lives. Going back to statistics, I can’t say they’re all enrolled. We don’t have that data yet from the federal government. But they’ve made contact, and now the Veterans have moved on from not only enrolling people but also to helping to connect them to the healthcare system. If the Veterans see someone who is having behavioral health issues, they know where to refer that person. So it’s gone beyond just the application process. These Veterans are making an impact on the health of our citizens.

Ryan: Through the funding provided by the Foundation, the New Jersey Hospital Association hired about 25 Veterans from all different wars. They are deployed all over the state in teams of five or six individuals, directly helping people enroll either in Family Care, Medicaid or the Affordable Care Act. It’s a neat program that has shown success.

Steve Adubato, PhD, is a four-time Emmy Award-winning 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 Star-Ledger columnist who has written extensively on doctor-patient communication. Risa Lavizzo-Mourey, MD, MBA, is President and CEO of the Robert Wood Johnson Foundation. Betsy Ryan, Esq., is President and CEO of the New Jersey Hospital Association.

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Becoming Advocates & Catalysts By Leila Mady, MD, PhD, MPH - Emerging Medical Leaders Advisory Committee Member

In the summer of 2009, I travelled to the Dominican Republic as part of a course titled Public Health Applications in Developing Countries. I was initially drawn to the experience because the challenges faced by the nation–those of unemployment, weak infrastructure, poverty–were similar to those I had witnessed in my family’s country of Lebanon. More than 100 students and faculty have made this trip to assist Haitians and Dominicans living in barrios (extremely impoverished neighborhoods) as well as Haitian communities of sugarcane workers living in geographically and socially isolated communities known as bateys. As part of our one-week field component, we implemented “deworming” clinics, health education programs, food distribution efforts and basic primary care. After witnessing the conditions in the bateys, I was saddened and outraged. Cement dwellings reminiscent of prisons serve as homes that are overcrowded and barely furnished. There is no clean water, electricity, toilets, schools or work. These people had come from Haiti looking for the work promised through the sugarcane industry. They came for the same reason my parents came from Lebanon to the United States–to build a better life. In addition to daily excursions to barrios and bateys, we visited a public hospital, Hospital Ricardo Limardo. Most beds did not have sheets; catheters drained into plastic containers; visitors slept on the beds of their ill loved ones; overcrowded rooms flowed into one another with no partitions. A plaque outside the maternity ward reminded new mothers that citizenship is granted only to a child with proof of at least one documented parent. For thousands of Haitians, gaining access to their birth certificates or passports can be a nearly impossible task. Without proper documentation, Haitian immigrants cannot legally get married, obtain a high school diploma or get a passport or national identity card required for voting or conducting business. They are trapped in the batey, unable to return to a place that was

MDADVISOR | FALL 2014

once home and unrecognized by the people of their new home. Seemingly unrecognized as people at all. Here we were, complete strangers, free to take photos and videos of the sick and dying with no regard to privacy. A part of me felt it was wrong to be there with my camera and uninvited presence. And yet, despite all that I am taught about patient privacy and confidentiality, I continued taking photos, hoping that I could bring back those images of suffering to show the world that unimaginable destitution really does exist. The greatest challenge of delivering medical care on the bateys was saying “No” due to limited resources. I learned to say, “I’m sorry. I know you are suffering. But there are others who are suffering more.” In one batey, giving the last cup of scabies shampoo to a child or providing a woman dying of end stage heart failure with our only supply of angiotensin receptor blocker meant not having treatments for the next patient in the next batey. It was the first time I realized that “humanistic” medical practice, full of respect and compassion, did not necessarily mean “fair” or “equitable” medical practice. The people of the bateys taught me that humanism in medicine is not limited to my physical presence or clinical experience of delivering medical practice firsthand but also encompasses the consciousness and understanding of suffering. Through such encounters and equipped with the tools to care for the vulnerable and the weak, we, as health professionals, have the power to change lives–to lift these forms of suffering from the shoulders of humanity. In fact, we have a profound obligation to do so. Let us all be advocates for our patients, champions for human justice and catalysts for change. Leila Mady, MD, PhD, MPH, is a resident in otolaryngology-head and neck surgery at the University of Pittsburgh and a 2014 Edward J. Ill Excellence in Medicine Scholarship Recipient.

Practical Lessons from HHS’s 2011-2012

Report on

HIPAA

Breaches

OF UNSECURED PHI By Leonardo M. Tamburello, Esq., CIPP/US

In a recent report, the Department of Health and Human Services (HHS) revealed that in a two-year period, from 2011 through 2012, the protected health information (PHI) of approximately 15 million individuals was compromised.1 A closer look at these data reveals important trends that point to areas where covered entities and business associates could best invest in securing PHI. These reports also suggest areas of known vulnerability in which HHS will be focusing its enforcement efforts in the future. Certainly, securing PHI is an ongoing and ever-evolving challenge for all members of the healthcare community. However, focusing compliance and security efforts on key areas of vulnerability is a strong first step in preventing breaches in your organization. ANATOMY OF A HIPAA BREACH Definition. Under the most recent HIPAA amendments, a “breach” is now defined as any acquisition, access, use or disclosure of PHI in a manner inconsistent with the Privacy Rule that compromises the security or privacy of the information.2 Exceptions. There are three exceptions to this definition. 3 1. The first applies in situations where there is a good faith, unintentional acquisition, access or use of PHI by a workforce member (or other authorized representative) made within the scope of his or her authority. 2. The second concerns inadvertent disclosures of PHI by someone authorized to access the information to another authorized person at the same organization. (For either of these first two exceptions to apply, the information must not be used or disseminated any further.) 3. Finally, the third exception applies if there is a good faith belief that the unauthorized person to whom a disclosure was made would not have been reasonably able to retain the information in question.

Risk Assessment. Unauthorized acquisition, access, use or disclosure of PHI is presumed to be a breach unless the covered entity or business associate demonstrates through a risk assessment that there is “low probability” that the PHI has been compromised.2 Such a risk assessment must consider, at a minimum: 1) the “nature and extent” of the PHI that has been compromised, “including the types of identifiers and likelihood of re-identification”; 2) the persons to whom the unauthorized disclosure occurred or who used the PHI; 3) whether the PHI was “actually acquired or viewed”; and 4) the extent that the risk to the PHI “has been mitigated.”2 Based on these definitions and criteria, the following analysis of HHS’s recent report summarizing PHI breaches that occurred in 2011 and 2012 should help you better understand the vulnerability of your PHI. SUMMARY OF 2011 AND 2012 BREACH REPORTS AFFECTING 500 OR MORE INDIVIDUALS All breaches of unsecured PHI must be reported to HHS as well as to the affected individuals.4 If a breach affects 500 or more individuals of a single state or jurisdiction, local media and HHS must be notified within 60 days.5 If fewer than 500 individuals are affected, HHS must be notified no later than March 1 of the year following the calendar year in which the breach was discovered.6 In compiling its data, HHS used this same threshold as a basis to distinguish different kinds of breaches.

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In 2011 and 2012, (at which time HHS defined “breach” somewhat differently*), breaches involving 500 or more individuals accounted for less than 1 percent of all reported incidents, yet accounted for almost 98 percent of the more than 15 million individuals whose PHI were compromised 1 for those two years. In this same time period, there were almost 47,000 reports of breaches involving fewer than 500 individuals, the majority of which (more than 39,000) came from healthcare providers.1 Parsing the data related to breaches affecting 500 or more individuals by year, entity type, general cause and location of PHI highlights the challenges and vulnerabilities confronting covered entities and business associates.** 2011 Breaches by Entity Type: In 2011, healthcare providers accounted for nearly two-thirds of breaches affecting 500 or more individuals, but, as indicated in Table 1, business associate breaches affected roughly twice as many individuals.1 Table 1. 2011 Breaches Affecting 500 or More Individuals by Entity Type Entity

Reports

% Reports Individuals % Individuals

Healthcare Providers

150

63%

3,763,041

33%

Health Plans

10%

313,379

Business Associates

27%

7,338,765

64%

Adapted from “Annual Report to Congress on Breaches of Unsecured Protected Health Information for Calendar Years 2011 and 2012,” by U.S. Department of Health and Human Services, Office for Civil Rights, n.d., p. 8.

2011 Breaches by General Cause: Although most reported breaches of PHI were the result of theft, as noted in Table 2, more than twice as many individuals were affected by the compromise of electronic media or paper.1 In addition, unauthorized access, hacking/IT incidents and improper disposal accounted for relatively few reports in 2011, affecting only 5 percent of individuals whose data were compromised.1 * The pre-HITECH Act definition of “breach” incorporated the “no harm, no foul” rule that did not require covered entities to report breaches of PHI that did not pose “a significant risk of financial, reputational or other harm to the individual.” ** Due to rounding, percentages in the statistics used throughout may not equal 100 percent.

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MDADVISOR | FALL 2014

Table 2. 2011 Breaches Affecting 500 or More Individuals by General Cause Cause

Reports

% Reports Individuals % Individuals

Theft

118

50%

2,735,416

24%

Unauthorized Access

19%

399,738

Lost Media or Paper

17%

6,173,012

54%

Hacking/ IT Incident

115,900

Improper Disposal

80,054

Unknown/ Other

1,911,065

17%

2011 Breaches by Location of PHI: Breaches affecting more than 500 individuals involving desktop computers and media other than paper, laptops, network servers, electronic medical records (EMRs) and email accounted for over 10 million (more than 88 percent) of all affected individuals in 2011.1 Nonetheless, as shown in Table 3, for that year, paper and laptop breaches accounted for nearly half of all reported breaches affecting 500 individuals or more.1

Table 3. 2011 Breaches Affecting 500 or More Individuals by Location of PHI and Individuals Affected Type

Reports

Paper

% Reports Individuals % Individuals 27%

321,731

Laptops

20%

437,770

Other/ Unknown

14%

8,054,479

70%

Desktop Computers

14%

2,049,875

18%

Other Electronics

13%

206,802

Network Servers

316,163

EMRs

19,423

< 1%

8,942

< 1%

2012 Breaches by Entity Type: In the following year, 2012, there were 222 reports of breaches affecting 500 or more individuals. Table 4 shows that, once again, healthcare providers reported the most breaches that affected the greatest number of individuals, with business associates a close second. Table 4. 2012 Breaches Affecting 500 or More Individuals by Entity Type Entity

Reports

% Reports Individuals % Individuals

Healthcare Providers

150

68%

1,592,558

49%

Business Associates

25%

1,370,880

42%

Health Plans

278,297

Healthcare Clearinghouse

< 1%

32,000

2012 Breaches by General Cause: Although the number of thefts involving PHI affecting 500 or more individuals remained largely steady between 2011 and 2012, approxi1 mately 1.5 million fewer individuals were affected. Similarly, as indicated in Table 5, although hacking/IT incidents increased only slightly (from 18 to 21 incidents), the number of individuals affected skyrocketed from 115,900 in 2011 to more than 870,000 in 2012. In addition, although the reports of improper disposal of PHI remained nearly the same, almost three times as many individuals (more than 214,000) were affected by these types of breaches.1

Table 5. 2012 Breaches Affecting 500 or More Individuals by General Cause Cause

Reports % Reports Individuals % Individuals

Theft

117

53%

1,164,452

36%

Unauthorized Access or Disclosure

18%

571,445

17%

Lost Media

12%

432,148

13%

Hacking/IT Incident

870,871

27%

Improper Disposal

214,601

Unknown/ Other causes

20,218

2012 Breaches by Location of PHI: With laptop losses leading all categories, more than 75 percent of all breaches involving 500 or more individuals in 2012 were handled by, 1 or stored on, electronic devices. Table 6 shows that among these numbers, breaches of network servers increased by almost 50 percent, more than tripling the number of individuals affected from the previous year. Also in 2012, the first reports of lost PHI due to EMRs were reported, affecting 1 over 120,000 individuals. Table 6. 2012 Breaches Affecting 500 or More Individuals by Location of PHI and Individuals Affected Type

Reports

% Reports Individuals % Individuals

Laptop

27%

654,158

20%

Paper

23%

386,065

12%

Network Server

13%

986,607

30%

Desktop Computers

12%

253,720

Other

10%

116,411

Other Electronics

463,702

14%

241,108

EMRs

121,964

Cumulatively, from September 2009 through 2012, the HHS Office for Civil Rights (OCR) received 710 breach reports affecting approximately 22.5 million individuals.1 COMPLIANCE STRATEGIES These data highlight key areas of vulnerability, particularly regarding electronic PHI. With the increasing adoption of certified electronic health record technology (CEHRT) through the Meaningful Use criteria established by the Centers for Medicare & Medicaid Services’ EHR Incentive Program, the potential for exploitation of ePHI vulnerabilities will continue to multiply.7 Indeed, many security experts believe that it is merely a matter of time before there is a monumental data affecting the healthcare sector, similar to what financial institutions and retailers have experienced in recent times.8 Strategies that could offset this risk include the following recommendations made in HHS’s 2011-2012 Report on HIPAA Breaches of Unsecured PHI.1

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“Employees should be given clear procedures to assure destruction of paper-based PHI that include documenting the proper disposition of the files.”

Updating Risk Assessments and Risk Management. OCR has already identified risk assessments and risk management as areas of increased compliance scrutiny. HIPAA requires that covered entities and their business associates must perform a thorough risk analysis that identifies and addresses potential risks and vulnerabilities to ePHI in its ecosystem, regardless of its form or location.9 This review should include all computers, tablets, mobile devices, USB flash drives and any manner of ePHI transmission. Conducting Regular Security Evaluations. Security evaluations should be regularly conducted and incorporated into any change in operations (such as facility, office or data relocation) that could potentially affect the security of PHI. Clear policies and procedures should be put into effect, requiring that adequate administrative, physical and technical safeguards remain in place during any transition period through to the resumption of normal operations. Such administrative safeguards might include policies requiring that executive leadership and/or management be involved in risk management and mitigation.10 Physical safeguards could include the requirement that computer screens displaying ePHI not be highly visible.11 Technical requirements might include unique user identifications, means of emergency access and automatic logoff.12

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MDADVISOR | FALL 2014

In addition, technical evaluations of new software, hardware, websites and other changes to IT infrastructure should be performed by qualified experts before these systems go live, to ensure that ePHI will not inadvertently be exposed. Illustrating this, a hospital’s misconfigured server that exposed the ePHI of 6,800 patients to the Internet resulted in a $3.3 million reso13 lution agreement with HHS. Maintaining Security and Control of All Portable Electronic Devices. Policies should be implemented requiring that ePHI stored and transported on portable electronic devices be properly safeguarded.14 Although encryption is not required by HIPAA, when properly implemented, encryption is among the best protections available for ePHI. The use (or lack thereof) of appropriate encryption has been the subject of several resolution agreements with HHS in 2014. In addition, clear policies and procedures concerning the receipt and removal of portable electronic devices and media containing PHI and how such information must be secured off-site should be implemented and enforced. Securing Disposal of PHI. Employees should be given clear procedures to ensure destruction of paper-based PHI that include documenting the proper disposition of the files. Similarly, if an electronic device is going to be reused or repurposed, it should first be securely wiped clean to confirm all ePHI is removed and rendered unrecoverable in accordance with HHS standards.15 Any discarded electronic devices should be securely destroyed, and that process should be verified and documented. Securing Physical Access Controls. Physical security should not be overlooked in the technological landscape of modern healthcare. Organizations should ensure that physical access to their facilities and workstations is limited to authorized employees and that employee access to PHI is restricted, unless required by their job function.15 Maintaining Employee Training. Privacy and security policies and procedures are virtually worthless if employees are not properly trained on their content and application. Regular training (and retraining) for all workforce members should be mandated, with an emphasis on high-risk areas, such as disclosure of PHI and security requirements. Employees should also be made aware of sanctions and other consequences for failing to follow proper security and privacy policies and procedures.15

“Organizations should ensure that physical access to their facilities and workstations is limited to authorized employees”

CONCLUSION In the first half of 2014, HHS entered into five separate resolution agreements with respondents paying more than $7 million in penalties. This already exceeds the $3.5 million in penalties assessed as part of resolution agreements in all of 2013.16 Enforcement activity can be expected to increase when HHS begins its planned audits of both covered entities and business associates in the coming months.17 Protecting the security of PHI, both in paper and electronic forms, will continue to be an evolving challenge for all healthcare providers. HHS’s Breach Report can be incorporated into your organization’s risk assessment by focusing its compliance and security efforts on the key areas of vulnerability. These areas, once again, include security risk assessments and risk management, ongoing security evaluations, control of all portable electronic devices, media disposal, control of physical access and employee training. Doing so will help ensure that you are not unnecessarily putting your PHI at risk. Leonardo M. Tamburello, Esq., CIPP/US, is a healthcare attorney with McElroy, Deutsch, Mulvaney & Carpenter, LLP in Morristown, NJ, and a Certified Information Privacy Professional/US. 1

U.S. Department of Health and Human Services, Office for Civil Rights. (n.d.). Annual report to Congress on breaches of unsecured protected health information for calendar years 2011 and 2012. www.hhs.gov/ocr/privacy/hipaa/administrative /breachnotificationrule/breachreport2011-2012.pdf.

45 C.F.R. § 164.402.

45 C.F.R. § 164.402(1).

45 C.F.R. § 164.404 and 164.408.

45 C.F.R. § 164.406 and 164.408.

45 C.F.R. § 164.408.

See, Department of Health and Human Services, Office of Inspector General. (2013, December). Not all fraud safeguards have been implemented in hospital EHR technology. http://oig.hhs.gov/oei/reports/oei-01-11-00570.pdf.

Pittman, D. (2014, July 1). Big cyber hack of health records is “only a matter of time.” Politico. www.politico.com/story /2014/07/cyber-hack-health-records-matter-time-108486 .html.

Department of Health and Human Services, Office of Civil Rights. (2010, July 14). Guidance on risk analysis requirements under the HIPAA security rule. www.hhs.gov/ocr/privacy/hipaa/ administrative/securityrule/rafinalguidancepdf.pdf.

U.S. Department of Health and Human Services. (2007 [rev.]). HIPAA security series 2: HIPAA security standards, administrative safeguards. www.hhs.gov/ocr/privacy/hipaa/administrative /securityrule/adminsafeguards.pdf.

U.S. Department of Health and Human Services. (2007 [rev.]). HIPAA security series, 3: HIPAA security standards, physical safeguards. www.hhs.gov/ocr/privacy/hipaa/administrative/ securityrule/physsafeguards.pdf.

U.S. Department of Health and Human Services. (2007 [rev.]). HIPAA security series, 4: HIPAA security standards, technical safeguards. www.hhs.gov/ocr/privacy/hipaa/administrative/ securityrule/techsafeguards.pdf.

Department of Health and Human Services. (2014, May 7). Data breach results in $4.8 million HIPAA settlements. www.hhs.gov/news/press/2014pres/05/20140507b.html; See also, Resolution Agreement (n.d.). [between Department of Health and Human Services and New York Presbyterian Hospital]. www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/ ny-and-presbyterian-hospital-settlement-agreement.pdf.

45 C.F.R. §164.312.

45 C.F.R. §164.310.

Note: For links to all resolution agreements between HHS and breaching entities, see www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/index.html.

Note: As described in 79 Fed .Reg. 36 (Feb. 24, 2014). www.gpo. gov/fdsys/pkg/FR-2014-02-24/html/2014-03830.htm.

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